Job DescriptionJob Description

Overview

Developmental Test Engineer - Senior

LOCATION: Patrick, SFB

JOB STATUS: Full-time

CLEARANCE: Secret

TRAVEL: 15-20% (Surge up to 35%)

Astrion has an exciting new opportunity for an SE-4 Developmental Test Engineer located at Patrick, SFB in Patrick Space Force, Florida. Supporting the Survivable Air Operations Center (SAOC) Developmental Test Engineers for the 96 Cyberspace Test Group.

REQUIRED QUALIFICATIONS / SKILLS

Master’s degree in a STEM field and a minimum of 10 years of relevant experience. Additional experience may be substituted for education.Must have an active US Secret security clearance; able to obtain and maintain a TS/SCI. U.S. Citizenship.Relevant experience must be in support of DOD NC3 systems (preferably with E-4B, NAOC or E-6B Mercury weapons systems).Systems engineering or operational experience that includes a fundamental knowledge of how NC3 platforms plan and execute operations.Proven ability to conduct data analysis and apply knowledge of engineering technologies across a wide variety of test activities.Exceptional written and oral presentation skills; including experience presenting technical briefings to senior leaders for internal and external customers.Must be willing to periodically travel to contractor EMD sites/labs as required; during active DT&E at EMD sites/labs, travel could surge to 35%.Ability to participate in SAOC flight testing; will include requirement to obtain a Class-III flight physical and Physiological Training (if not previously obtained).

 

PREFERRED QUALIFICATIONS / SKILLS

An active Top-Secret clearance is highly desired.A working knowledge and experience with advanced communications systems spanning ground, air, and space operational domains; AEHF experience is highly preferred.Recent experience with one or more of the following: E-4B/NAOC Mission Systems (Technical Control, DSSII-A, SLCS, Comm/Data Operator, SHF Operator, LF/VLF Operator, Battle Staff)E-6B/TACAMO Mission Systems (Airborne Communications Technician, Communications Office, Battle Staff)SATCOM OperationsAn understanding of developmental test and evaluation processes, specifically, acquisition program development and detailed knowledge of Air Force C2 test methodologies including DODI_DAFI 99-103 is highly desirable.CCNA and/or Network/Security+ certifications is a plus.

RESPONSIBILITIES

Perform as member of the SAOC DT&E team charged with executing developmental testing on the Air Force’s newest NC3 platform.Apply systems-engineering expertise and NC3 experience to develop rigorous test and evaluations strategies for the SAOC Missions Systems to ensure systems requirements are met.Translate weapon systems requirements into comprehensive test strategies with a focus on evaluating functionality and compliance with military specifications.Review and compare test data for correctness relative to systems requirements and prepare deficiency reports for formal disposition and possible fixes by the prime contractor.Interact with multi-disciplined engineering and test communities to develop strategies for testing SAOC mission systems and validating design methodologies.Prepare and report technical test results to ETO leadership, SAOC Program Management personnel and Integrated Test Team (ITT) members as appropriate.Complete training as required by the company and government customer.

#Air Force Cyber Division

#CJ

#LI-BT2

#floridajobs

#CTG

Air Force

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Job DescriptionJob Description

Overview

The Work

The IT Asset Support Technician assists the Base Custodian in organizing and properly maintaining the wide inventory to include warehouse IT equipment

This position performs all duties and responsibilities in accordance with the Mission, Vision, and Core Values of Cayuse.

Responsibilities

Key Responsibilities:

Support logistics, the contractor may use personnel without a secret clearance, but they must pass and have a favorable and current National Agency Check (NAC). Personnel will be granted limited network access. Personnel who have designated access to government’s DPAS IT asset system shall have a secret clearance.Provide inventory support to directorates of approximately 9000 items within DPAS.ensure all accountable IT items are accepted on another EC account before release (3-6 times daily).dispose of all packing and waste material IAW, AF, and DoD guidance (4-6 pallets per month).Dispose of all hardware and software products using processes and checklists that comply with applicable lAW Government policies.Complete and annual accounting and monthly accounting of 10% for all trackable assets IAW applicable policies and laws.Account for all Government Furnished Equipment (GFE) provided to its work force IAW inventory reporting below.Ensure that it properly accounts for GFE that transitions within the IT support areas of operation.Other duties as assigned.

Qualifications

Qualifications – Here’s What You Need:

Bachelor’s degree.Possess Security + certification.Secret Security Clearance.Must be able to pass a background check. May require additional background checks as required by projects and/or clients at any time during employment.Must possess problem-solving skills.Exceptional communication skills, both oral and writtenAbility to respond effectively to customers with a sense of urgency.Proficient in Microsoft and Adobe toolsets, including Excel, Word, PowerPoint, Acrobat, etc.Highly motivated with the ability to handle and manage multiple tasks at any one time.Ability to forge new relationships, individual and teaming in nature.Must be a Self-starter, that can work independently and as part of a team.

Our Commitment to you / overview of benefits:

Medical, Dental and Vision Insurance; Wellness ProgramFlexible Spending Accounts (Healthcare, Dependent Care, Commuter)Short-Term and Long-Term Disability optionsBasic Life and AD&D Insurance (Company Provided)Voluntary Life and AD&D options401(k) Retirement Savings Plan with matching after one yearPaid Time Off

Reports to: Program Manager

Working Conditions:

Professional office environment.Must be physically and mentally able to perform duties extended periods of time.Ability to use a computer and other office productivity tools with sufficient speed to meet the demands of this position.Must be able to establish a productive and professional workspace.Must be able to sit for long periods of time looking at computer screen.May be asked to work a flexible schedule which may include holidays.May be asked to travel for business or professional development purposes.May be asked to work hours outside of normal business hours.

Other Duties: Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Cayuse is an Equal Opportunity Employer. All employment decisions are based on merit, qualifications, skills, and abilities. All qualified applicants will receive consideration for employment in accordance with any applicable federal, state, or local law.

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Job DescriptionJob Description

Security Clearance: TS/SCI

Location: Offutt AFB, NE

Job Type: Full-Time

Target Salary Range*: $140,000 - $200,000.

*This represents the potential salary range for this position depending on education level, years of experience and/or certifications in addition to other position specific requirements which may impact salary

Position Overview:

USSTRATCOM is a Combatant Command responsible for strategic deterrence, nuclear operations, and enterprise IT services essential to national security. It oversees Nuclear Command, Control, and Communications (NC3), Joint Electromagnetic Spectrum Operations (JEMSO), Global Strike, and Missile Threat Assessments, working closely with other Combatant Commands, Services, and defense agencies. SCITLS will be a key component that will ensure mission success and the safety of the U.S. and its allies by providing 24/7 IT services and network support for NIPRNet, SIPRNet, JWICS, and SAP/SAR environments.

Qualifications:

Education:

BA/BS in engineering (systems engineering preferred)

Experience:

2-3+ years minimum of model-based systems engineering

Skills:

CameoUMLSysML

Certifications:

ITIL 4 FoundationFITSP-D or GDSA or CASP+ or CCSP or Cloud+ or CSSLP or GSEC

Preferred Qualifications:

Certifications in systems modeling, OMG OCSMP preferredINCOSE membership, CSEP preferredDemonstrated leadership in applying systems engineering in organizations Read Less

Job DescriptionJob Description

The Garrett Group is seeking a highly skilled Information Security Specialist to ensure the security and integrity of mission-critical IT systems. The ideal candidate will have extensive experience securing systems and applications in classified environments, implementing cybersecurity best practices, and ensuring compliance with DoD security policies and regulations.

Key Responsibilities:

Utilize Xacta or similar security applications for Authorization to Operate (ATO) processes.Secure systems and applications across multiple infrastructures, including cloud, hypervisors, and bare metal environments.Implement and enforce security policies in compliance with NIST, DoD, and IC regulations.Conduct risk assessments and vulnerability analyses to identify and mitigate potential security threats.Develop and maintain security documentation, including system security plans and standard operating procedures.Monitor and respond to security incidents, implementing corrective actions as necessary.Collaborate with IT teams to ensure security is integrated into system architecture and operations.Assist with security audits and ensure compliance with government regulations.

Minimum Qualifications:

Must possess a current DoD 8570.01-M IAT Level II certification or current DoD 8140 certification.**Minimum of 10 years of experience in cybersecurity and system security roles.Strong knowledge of Xacta or similar security applications for ATO processes.Experience securing systems and applications in cloud, hypervisor, and bare metal environments.In-depth understanding of NIST, DoD, and IC security policies and compliance frameworks.Ability to conduct risk assessments, vulnerability analyses, and security audits.Strong communication skills and ability to work collaboratively in a team environment.

**Approved Certifications for IAT Level II:

CompTIA Security+CCNA SecurityCySA+GICSPGSECSSCP

Additional Requirements:

Ability to travel within the Continental United States (CONUS) approximately twice per calendar year.Top Secret Clearance with eligibility for SCI access

The Garrett Group is an Equal Opportunity Employer.

Job Posted by ApplicantPro
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Job DescriptionJob Description

Test Technician I
Location: Sparks Glencoe, MD
Schedule: Monday–Friday | Day Shift
Pay Rate: $25.00/hour

Job Overview

The Test Technician I performs production assembly operations along with complete system analysis, testing, and performance optimization of moderately complex instruments. This role involves basic electrical, mechanical, and software troubleshooting to diagnose issues in non-functioning test equipment and implement solutions based on defined pass/fail criteria. The technician identifies and escalates testing issues and serves as a subject matter expert in instrument functional performance.

Key Responsibilities

Build, integrate, and understand the full assembly process and requirements for instruments in the production areaExecute and interpret test instructions for at least one moderately complex instrument, including functional and release testingAnalyze test results and data to determine pass/fail outcomes and recommend corrective actionsOptimize system performance, including precision of movement and/or light systems, using test dataIdentify defects and recommend design or process improvementsRead and interpret drawings, work instructions, and workmanship standardsTrain and support associates in mechanical assembly and testing activitiesComplete production activities in compliance with regulatory requirements and BD safety and quality standardsProcess and disposition Quality Notifications (QNs)Interface with Manufacturing Engineering, Quality, Planning, and Purchasing teams as neededPerform material handling for raw materials and sub-assembliesMaintain a safe, clean, and organized work environment in accordance with housekeeping standardsFollow Good Manufacturing Practices (GMP), safety policies, and company proceduresWork overtime as required to meet business needsPerform other duties as assigned

Qualifications

Education & Experience

High School Diploma or GED with 6 years of manufacturing experience, orAssociate (AA) technical degree with 2 years of manufacturing experienceExperience working in a regulated manufacturing environment is required

Required Skills & Competencies

Ability to support testing of moderately complex instrumentsProven leadership skills with the ability to mentor and coach other associatesStrong accountability for results and continuous process improvementDemonstrated commitment to Continuous Improvement and Lean Manufacturing principlesExperience with mechanical tools (e.g., torque drivers, gauges, bits)Proficiency in reading drawings and measuring/interpreting dimensions and requirementsEffective time management across multiple production ordersStrong teamwork and collaboration skillsAbility to work within established quality systems and proceduresFlexibility to manage frequent changes in assignments

Technical & Professional Skills

Proficient in English (reading, writing, and basic documentation)Ability to analyze charts, follow diagrams, and perform basic arithmeticBasic computer skills, including use of Windows-based systemsStrong math and analytical capabilitiesAbility to use independent judgment to plan work, troubleshoot, and problem-solveStrong communication and leadership skills

If you are interested, please send an up-to-date resume to jschafer@alinestaffing.com Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Engineering Technical Leads ETLs

Project Scope:

Provide ETL Support Services.

Preparation of front-end planning documents.Lead the design process.Provide value engineering / creative problem solving.Participation in the development of the sourcing strategy for projects.Evaluate the design library against the project scope and issue relevant specifications or standards.Review of the projects plans for adherence to Amgen engineering standards and specificationsIdentification of possible deviations to the site specifications. Submittal and approval of variance.Ensure Factory Mutual loss prevention recommendations are issued and addressed in the design.Ensure EHSS requirements are considered in the design.Technical support during project execution and lead for discrepancies.Liaison to engineering technical authorities, subject matter experts, consultants, and engineer of record.RFI and submittal review process.Track design progress against plan and ensure alignment with overall project’s schedule.Engineering change management.Consultant to site commissioning and qualification work stream.Consultant to site change control evaluation process.Point of contact between equipment vendors and the site.Establish method to manage information and documents. e-Builder preferred for capital projects.Factory acceptance test planning.Ensure project plans and details are fit to introduce equipment.Develop, submit, and approve design qualification report (for level 1 systems), and DDR for level 2 and 3.

Delivery Criteria

Provide ETL Support Services to support the project

Scope of facilitiesProject requirementsDesign PlanDesign review reportsDesign qualification reportConceptual design documentse-Builder processesSubmittalsRFIsTurnover packagesEngineering Change NoticesOther ActivitiesField visits to confirm existing documentation and installations.

Qualifications:

Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

#LI-ZL1

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Job DescriptionJob Description

Junior Access Control Specialist

Overview: Aether Aerospace is seeking a motivated and detail-oriented Junior Physical Security Specialist to support security operations at Fleet Readiness Center Aviation Support Equipment (FRC ASE). This position plays a key role in maintaining facility security, managing access control systems, and supporting compliance with Navy and COMFRC security directives.

The selected candidate will work closely with government security staff, gaining valuable hands-on experience in physical security operations, facility management, and security program administration.

Duties/Responsibilites:

Administer the command Key Control Program in accordance with COMFRC instructions. Manage and maintain the facility's electronic access control system. Assist government staff and contractors with facility access and credentialing support. Maintain and update security-related instructions and documentation in compliance with Navy and COMFRC directives, including: Continuity of Operations Plans (COOP)/ Emergency Action Plans (EAP) Coordinate with emergency response personnel, including fire and police departments, as required. Serve as a liaison between the COMFRC Security Director and FRCASE leadership, operations, and facility personnel. Support and coordinate annual Physical Security Surveys. Assist leadership with security-related training initiatives and awareness programs.Perform additional security-related duties as assigned by the COMFRC Security Director.

Qualifications Required:

High School diploma or equivalent. Less than four (4) years of experience performing duties related to physical security, facility security, access control, or a related field. Ability to work effectively under the guidance and oversight of senior personnel. Strong organizational, communication, and problem-solving skills. Ability to handle sensitive information with professionalism and discretion.Ability to obtain Secret clearance.

Qualifications Desired:

Familiarity with Navy or Department of Defense security procedures and directives. Experience with electronic access control systems or key control programs. Prior experience supporting military, government, or industrial facilities. Proficiency with Microsoft Office applications.Active security clearance.

TSA is committed to pay transparency for our applicants and employees. The salary range for this position is $20-$23/hr. Actual compensation will be determined based on several factors permitted by law. JHNA/TSA provides for the welfare of its employees and their dependents through a comprehensive benefits program by offering healthcare benefits, paid leave, retirement plans, insurance programs, and education and training assistance.

JHNA/TSA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, age, national origin, disability, status as a protected veteran, or any other protected characteristic.

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Job DescriptionJob Description

Position Summary

LCI is seeking a Telephone Switch/Avaya Operator to install, configure, and maintain Avaya Aura Communications and Session Manager IP telephony systems. The On-Site Call Manager Technician will lead our on-site team at Dover Air Force Base in support of the 436th Communications Squadron (436 CS).

Individuals must be able to attain and maintain a valid US Government security clearance to be retained in the position

Duties & Responsibilities

Lead the installation, configuration, and end-to-end maintenance of Avaya Aura Communication Manager and Session Manager.Manage and troubleshoot complex IP telephony systems to ensure high availability and seamless communication.Perform routine maintenance, system upgrades, and advanced troubleshooting for mission-critical voice environments.Provide management to complex communications project which may include IT, Network, Communications, and Telecommunications.Manage IP telephony and VoIP technologies, including network or voice quality issues.Perform patches, upgrades, and migrations for communication systems.Manage enterprise-wide UC Implementation: migrations from legacy Avaya/Centrex systems to SIP-based unified communications platforms.Provide advanced technical troubleshooting support for voice systems and troubleshooting voice-over internet protocols (VoIP).Perform moves, additions, changes (MACs) and manage call center environments operational support.Work with IT teams to address user requests and provide system training.Configure Avaya Aura platforms, including IP Office and Communication Manager.Lead troubleshooting support for key telephony system issues (IVR, Avaya, Verint) and ensuring high availability. Provide complete Operation and Maintenance (O&M) on the Local Session Controller (LSC) and all peripheral equipment to include any and all security requirements.Technical Support: Managing IP telephony and VoIP technologies, including network or voice quality issues.Provide advanced expertise and proven experience with system operations and support, radio communications, antenna/tower communications, telecommunications.Read, interpret, and develop engineering specifications and drawings.Understand technical documents, architectural plans, floor plans, site survey reports, test plans, schedules, procedures and acceptance test reports, equipment performance, operational test and feedback to the proper individuals/departments.Configuration management to evaluate proposed changes/upgrades to the infrastructure (hardware/software).Provide management and reporting of work request utilizing the Army’s Enterprise Remedy automated work order system, to track and work customer requests.Input data of work requests that are processed in the Workload Analysis Report.Support troubleshooting and resolution of voice/data communication installations, upgrades and problems across the enterprise.Supervise team of multi-disciplined telecommunications professionals.Manage training and certification of employees.Must be detailed and safety oriented.

This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor

Education & Experience Requirements

BS in IT-related or Telecommunications or equivalent technical degree or equivalent experienceMinimum of 5+ years of experience in telephone installation, voice/non-voice communication systems, and supervisory leadership.Avaya telephony administrationVoIP, SIP protocols, networking, and Avaya Aura platformsDoD 8570 IAT Level II certification (e.g., CompTIA Security+ CE, CCNA Security) Avaya Call Manager certification (Required). Clearance: Ability to obtain and maintain a government security clearance.

Skill & Certification Requirements

Avaya Certification required IAT Level II certification requiredProficient in understanding, reading, writing, and speaking English.Ability to pass a Criminal Background Investigation and meet all requirements to obtain and maintain a Common Access Card (CAC) and unescorted base access.Demonstrated experience managing enterprise-level DoD telecommunications switching systems, inside/outside plant (ISP/OSP) maintenance, and technical teams.Familiarity with Avaya Communication Manager, Session Manager, System Manager, and Communication Control Toolkit (CCT).Avaya Aura Platforms Avaya System Management: Installing, configuring, and maintaining Avaya Aura Communication Manager (CM), System Manager (SMGR), Session Manager (SM), and Avaya CMS.SIP trunking and VoIP troubleshooting.SharePoint Documentation Proficient in troubleshooting techniquesMay be required to lift more than 50lbsPosition requires sitting, standing, keeling for long periods of timeLCI is an Equal Opportunity Employer/Veterans/Disabled

Leader Communications is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email hr@lcibest.com

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Job DescriptionJob Description

LOCATION: Remote – United States | Travel to Puerto Rico required approximately once per month

Site in Puerto Rico (Juncos/Gurabo/Las Piedras)

We are seeking a Project Scheduler to support capital and facility improvement projects at a pharmaceutical manufacturing site. The Project Scheduler will be responsible for developing, maintaining and analyzing detailed project schedules, primarily using Microsoft Project, for engineering, shutdown and improvement initiatives.

This role is primarily remote within the United States and requires travel to Puerto Rico approximately once per month to support on-site project activities and collaboration with key stakeholders. The Project Scheduler will work closely with Project Managers, Engineering, Maintenance, Operations, EHS and external contractors.

This is a contract-based opportunity for an independent professional willing to work at client site.

Main Responsibilities

Project Scheduling & PlanningDevelop, update and maintain integrated project schedules in Microsoft Project for multiple concurrent projects.Break down project scope into activities and work packages with appropriate durations, logic ties and constraints.Identify and manage critical path, near-critical activities, and key milestones to support decision-making.Coordinate with Project Managers and technical leads to ensure schedules reflect realistic execution plans.Schedule Control & ReportingTrack schedule progress, update actual start/finish dates, and maintain look-ahead schedules (weekly/monthly).Analyze variances versus baseline and prepare schedule impact assessments for scope changes and issues.Generate regular schedule reports, charts and dashboards for management and stakeholders.Support integration of schedule information with cost and resource data when required (basic project controls).Coordination & Stakeholder InterfaceFacilitate schedule review meetings with Project Managers, Engineering, Operations, Quality and contractors.Gather input from discipline leads to update activities, constraints and resource assumptions.Communicate clearly schedule risks, constraints and potential conflicts between projects or operations.Support planning for shutdown windows, tie-ins, and other high-impact activities to minimize production impact.Compliance & DocumentationEnsure that schedule development and updates follow internal procedures and project management standards.Maintain proper documentation of schedule baselines, revisions and approvals.Support preparation of presentations, reports and documentation for audits or management reviews as needed.

General Requirements

Bilingual (Spanish and English) – written and spoken.Intermediate to advanced proficiency in Microsoft Project is required.Proficiency in Microsoft Office 365 (Excel, Word, PowerPoint).Strong analytical, organizational and time-management skills.Ability to work on site and to adjust schedule (extended hours/weekends) during critical projector shutdown windows.

Education Requirements

Bachelor’s degree in Engineering, Project Management, Business, or related discipline; or equivalent relevant experience.

Experience Requirements

Minimum 3–5 years of experience in project scheduling, planning or project controls in industrial, pharmaceutical or manufacturing environments.Demonstrated experience creating and managing schedules in MS Project (intermediate to advanced level).Experience supporting capital projects, shutdowns, maintenance turn arounds or facility improvement initiatives.Expertise with project management concepts and tools (scope, schedule, cost, risk, change control).Experience working in or supporting GMP-regulated environments is preferred.

Preferred

Experience in pharmaceutical or medical devices manufacturing and capital projects.Project Management course is a plus.

Key Skills

Strong attention to detail and accuracy in schedule data.Ability to interpret technical information and convert it into logical activities and dependencies.Effective communication skills to present schedule information to technical and non-technical audiences.Team-oriented, proactive and comfortable working in a fast-paced, changing environment.

Compensation

Hourly rate will be defined based on experience, skills and alignment with project requirements.

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Job DescriptionJob Description

This position is for future work

Data Analyst

Location: Offutt AFB, NE

Clearance: Active TOP SECRET with eligibility for SCI.

Join a Mission-Driven Team at The GARRETT GROUP

At The GARRETT GROUP, we believe the best solutions begin with a great team of people. When you join us, you become part of a collaborative, mission-focused community committed to excellence in everything we do. We take pride in supporting our nation's most critical missions while creating an environment where our employees can thrive.

Our team members enjoy a comprehensive benefits package-including a competitive 401(k) with company match, generous Paid Time Off, flexible work schedules, medical, dental, and vision coverage, short-term disability, and company-paid life insurance-because taking care of you enables you to take care of the mission.

Position Overview

The GARRETT GROUP is seeking an experienced Data Analyst to support advanced analytical, data management, and machine learning initiatives in a dynamic Department of Defense environment. The selected candidate will be responsible for designing and implementing enterprise-level data collection strategies, managing and analyzing large and complex datasets, and delivering actionable insights to support operational and strategic decision-making.

This role requires strong technical expertise in data science methodologies, machine learning model development, statistical analysis, and business intelligence tools. The ideal candidate will possess the ability to lead analytical projects, collaborate across multidisciplinary teams, and communicate complex findings to technical and non-technical stakeholders.

Key Responsibilities

The Data Analyst will design and manage data collection processes, analyze large and complex datasets, develop machine learning models, and create analytical products using Python, R, SQL, and Business Intelligence tools. The role supports mission decision-making through data visualization, automation, project leadership, Agile collaboration, and delivery of actionable insights to technical and senior leadership teams.

Required Qualifications

Bachelor's degree or higher in Data Science, Computer Science, Statistics, Mathematics, Engineering, Information Systems, or a related technical discipline. Minimum of 7 years of experience designing and implementing data collection strategies, data management solutions, and advanced analysis of large, complex datasets. Demonstrated experience leading analytical or technical projects and coordinating cross-functional teams. Direct experience developing, testing, and deploying Machine Learning models. Expertise with: Python R Business Intelligence tools Data cleaning and data wrangling methodologies Proficiency with: Structured Query Language (SQL) Database management concepts and practices Familiarity with Agile methodologies and participation in sprint planning, backlog grooming, and retrospectives. Strong analytical, problem-solving, and critical-thinking skills. Excellent written and verbal communication skills, including the ability to brief senior leadership.

The GARRETT GROUP is an Equal Opportunity Employer.

Job Posted by ApplicantPro
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Job DescriptionJob Description

Note: This position is for future work.

Front End Developer

Location: Offutt AFB, NE

Clearance: Active TOP SECRET with eligibility for SCI.

Join a Mission-Driven Team at The GARRETT GROUP

At The GARRETT GROUP, we believe the best solutions begin with a great team of people. When you join us, you become part of a collaborative, mission-focused community committed to excellence in everything we do. We take pride in supporting our nation's most critical missions while creating an environment where our employees can thrive.

Our team members enjoy a comprehensive benefits package-including a competitive 401(k) with company match, generous Paid Time Off, flexible work schedules, medical, dental, and vision coverage, short-term disability, and company-paid life insurance-because taking care of you enables you to take care of the mission.

Position Overview

The GARRETT GROUP is seeking an experienced Front End Developer to support the design, development, and enhancement of modern web-based applications and data visualization platforms in support of Department of Defense mission requirements. The selected candidate will develop responsive user interfaces using modern web technologies, with a strong emphasis on the React framework, while integrating data-driven applications, dashboards, and visualization capabilities to support operational analysis and decision-making.

The ideal candidate will possess strong front-end development expertise, experience with MAVEN Smart Systems, and the ability to work collaboratively within Agile development environments supporting complex mission-focused initiatives.

Key Responsibilities

The Front End Developer will design and maintain responsive web applications and interactive dashboards using React and modern visualization libraries, while integrating APIs, RSS feeds, and database-driven solutions to support mission analysis and decision-making. The role includes automating workflows with Python or JavaScript, supporting data visualization and application performance, collaborating within Agile development teams, and delivering intuitive, scalable user interfaces for operational environments.

Required Qualifications

Bachelor's degree or higher in Data Science, Computer Science, Data Analytics, Business Analytics, Management Information Systems, Statistics, Applied Mathematics, Applied Physics, or a related technical discipline. Minimum of 7 years of combined front-end development and data visualization experience. Demonstrated experience developing user interfaces using the React framework and modern web technologies. Experience with MAVEN Smart Systems. Experience developing interactive web-based dashboards and visualizations using modern visualization libraries. Experience supporting database-driven applications, version control, and database normalization practices. Experience automating tasks using Python, JavaScript, or similar scripting languages. Experience querying external databases through APIs and RSS feeds. Familiarity with Agile development methodologies and working within cross-functional technical teams. Strong analytical, problem-solving, and communication skills.

The GARRETT GROUP is an Equal Opportunity Employer.

Job Posted by ApplicantPro
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Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Specialist QA (5:00 pm - 5:30 am)

SUMMARY
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.

FUNCTIONS
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.

EDUCATION
-Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR

Responsibilities
• Execute Quality disposition (approval or rejection) of bulk drug substances.
• Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
• Ensure that deviations from established procedures are identified, reported, and documented per procedures.
• Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations.
• Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress.
• Ensure completion of required training and maintain assigned training adherence to support successful task execution.
• Collaborate and partner cross functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures.
• Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed.
• Alert senior management of quality, compliance, supply, and safety risks.
• Provide support and oversight for New Product Introduction (NPI).

Attributes:

• Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
• Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency.
• Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
• Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
• Validated experience serving as Quality Contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
• Strong organizational skills, with the ability to drive assignments through successful completion.
• Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
• Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

We are seeking an IT HelpDesk Manager!

Central & Southeastern Ohio Region

Join our Team!

Integrated Services for Behavioral Health (ISBH) is a community-minded, forward-thinking behavioral health organization helping people along the road to health and well-being. We meet people in their homes and communities and help connect them to the resources they need. We serve Southeastern and Central Ohio with a comprehensive array of behavioral health and other services, working with local partners to promote healthy people and strong communities. All of our services are intended to be collaborative and personalized for the individual.

The IT Helpdesk Manager is responsible for the strategic oversight, operational management, and continuous improvement of the IT Helpdesk function across the organization. This role ensures the delivery of high-quality, responsive, and customer-focused technical support services while aligning helpdesk operations with organizational priorities, clinical workflows, and enterprise IT standards.

In addition to maintaining hands-on technical competency, the Helpdesk Manager provides direct supervision, coaching, and performance management for a team of helpdesk technicians. The role is accountable for service delivery metrics, ticket management, staff development, process optimization, and the implementation of best practices that enhance end-user satisfaction and operational efficiency.

The salary for this position is $75,006.00 to $95,190.00 annually, based on experience

Essential Functions

Provide leadership, oversight, and strategic direction for the Information Technology Helpdesk function, ensuring high-quality, customer-focused technical support services across the organization.Directly supervise, mentor, and manage a team of Helpdesk Technicians, fostering a positive, accountable, and high-performing work environment.Manage, prioritize, and oversee all inbound IT support tickets, ensuring timely resolution, appropriate escalation, and minimal operational disruption.Establish, monitor, and report on helpdesk performance metrics, including service level agreements (SLAs), response times, resolution times, and customer satisfaction.Serve as the primary escalation point for complex or high-impact technical issues, ensuring prompt resolution and clear communication with stakeholders.Develop, implement, and maintain helpdesk policies, procedures, and standard operating practices aligned with organizational and IT governance standards.Lead continuous improvement initiatives to optimize helpdesk workflows, ticket management processes, and service delivery outcomes.Oversee the creation and maintenance of comprehensive documentation, including knowledge base articles, troubleshooting guides, and training materials.Provide advanced technical troubleshooting support for hardware, software, network, and system-related issues as needed.Ensure proper account management processes, including user provisioning, access control, and security compliance.Oversee endpoint device lifecycle management, including deployment, maintenance, refresh, and decommissioning in accordance with established procedures.Monitor and ensure completion of preventative maintenance activities across all supported systems and endpoint devices.Lead onboarding and ongoing training for helpdesk staff, ensuring technical competency and adherence to service standards.Conduct training sessions for staff and end users to promote system knowledge, efficiency, and self-service capabilities.Collaborate with IT leadership and cross-functional departments to support system implementations, upgrades, and organizational initiatives.Maintain oversight of IT inventory management processes, ensuring accurate tracking and documentation of all equipment.Ensure all helpdesk interactions are properly documented within the ticketing system in a timely and consistent manner.Follow up on support requests and analyze trends to improve service quality and reduce recurring issues.Ensure adherence to cybersecurity protocols, including virus remediation, endpoint protection, and user awareness.Participate in organizational and IT governance initiatives, contributing to policy development and compliance efforts.Evaluate the performance of helpdesk staff, conduct formal performance reviews, and recommend appropriate personnel actions.Supervise and coordinate the activities of staff members through regular team meetings, coaching sessions, and ongoing communication.Adhere to the ISBH Confidentiality Policy.Participate in New-Hire Orientation as needed.Travel to offices throughout the service area is required.All other duties assigned.

Minimum Requirements:

Education/Licensure

A high school diploma or GED equivalent is required.A bachelor’s degree in Information Technology, Computer Science, or a related field is required.

Experience

5 years of progressive IT support experience is required3 years of supervisory experience in IT or a related field is required.Experience managing helpdesk operations in a healthcare or similarly complex environment is preferred.Experience with account provisioning, system access controls, and security best practices is required.

Knowledge, Skills, and Abilities

Advanced knowledge of helpdesk ticketing systems, endpoint management, and user support processes is required.Proficiency in troubleshooting hardware, software, networking, and access-related issues is required.Ability to lead, motivate, and manage technical teams is required.Advanced organizational and process management skills are required.The ability to analyze performance metrics and implement data-driven improvements is required.Excellent communication and interpersonal skills with a strong customer service orientation.Ability to manage deadlines within a fast-paced, high-volume environment is requiredA valid driver's license is requiredAn appropriate level of auto insurance coverage is requiredThe ability to operate in an Internet-based, automated office environment is requiredThe ability to maintain a high-speed internet connection is required

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer are requiredThe ability to transport IT equipment is requiredMust be able to lift up to 15 pounds at times

Enjoy a great work environment with an excellent salary, generous paid time off, and a strong benefits package.

Benefits include:

MedicalDentalVisionShort-term DisabilityLong-term Disability401K w/ Employer MatchEmployee Assistance Program (EAP) provides support and resources to help you and your family with a range of issues.

To learn more about our organization: https://ISBH.org

OUR MISSION
Delivering exceptional care through connection

OUR VALUES
Dignity - We meet people where they are on their journey with respect and hope

Collaboration - We listen to understand and ask how we can best support the people and communities we serve

Wellbeing - We celebrate one another's strengths, and we support one another in being well

Excellence - We demand high-quality care for those we serve, and we are a leader in how we care for one another as a team

Innovation - We deeply value a range of perspectives and experiences, knowing it is what inspires us to stretch past where we are and reach towards what we know is possible

We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Analytical Services Scientist

Summary:

Will provide Analytical Technology expertise for Quality Control requirements within the introduction of new products to the Site, development / transfer / validation of analytical methodologies & technologies, instrumentation services & technologies, and the resolution of complex and critical analytical investigations. Will provide support to the QC Laboratory to ensure QC Systems maintenance. Participate as the Quality representative on steering committees, ad-hoc projects, introduction of new system, upgrades for the Quality Control Laboratory to ensure that requirements are identified and carried out following procedures and SLC (System Life Cycle processes) as required. Ensure the operational efficiency and excellence of the organization by designing, documenting and providing solutions to new business requirements, trends, and concepts appropriately through the latest technological paths. Will maintain Laboratory efficiency and capacity metrics. The incumbent understands the internal and external customer’s business requirements and business process management, and then translates them to process, system or software requirements.

Responsibilities:

Collaborate with functional areas to determine regulatory requirements, validation requirements, business & functional risks and work within cross-functional project teams in the development of validation deliverables or systems upgrades for Laboratory equipment and computer systems in Quality or within the Quality Systems.Generate, develop, evaluate, review and approval of Validation / Automation Documentation (validation plans, protocols and final reports), performance qualification, system life cycle approach to ensure compliance and regulatory requirements from the QC perspective.Coordination / direction and active participation in the validation of site laboratory equipment, facilities, utilities, processes and software in compliance with company policies, Federal Drug Administration (FDA) regulations, European current Good Manufacturing Practices (cGMP’s) and Good Automated Manufacturing Practice (GAMP) standards.Performs the method development, method validation, method transfer and method verification of new or existing products, guaranteeing implementation of a feasible and efficient process. Performs process Failure Mode and Effects Analysis (FMEA’s) and other process verification activities following current Regulatory Guidelines.Conduct, write and manage laboratory investigations.Must have excellent technical writing, experience on root cause analysis and CAPA plan determination.Maintenance of Investigations Metric to support Quality Council QC Metrics.Supports process activities to achieve a successful on time resolution of incidents and deviations and enhances quality and effectiveness of laboratory systems, including change control and Corrective Action /Preventive Action (CAPA) towards optimization laboratory processes to assure effectiveness, robustness, and compliance.Lead / Performs special project as assigned. Participate as a team leader or a member of the project teams where needed and help provide direction on future enhancements to the systems.Assist in solving problems during validation process, system upgrades or investigations and address or seek advice from SMEs (Subject Matter Experts) on issues such as deficiencies, deviations and change control.Administrate Quality Computer Systems and perform periodic review as required. Knowledge on Laboratory Information Management Systems (LIMS Vantage or LIMS Lab Ware) is desired. Full knowledge on Chromatographic Data Management System (CDMS) as Empower.Troubleshoot of methods, and or instruments as needed. Coordinate and manages outside services as required for calibration, maintenance, evaluations, quotes, etc. Perform calibration or maintenance as required. Manage, store, handle, dispose, label and inspect laboratory waste following Environmental Protection Agency (EPA), Environmental Quality Board (EQB) and site requirements procedures, guides and policy.Knowledge of Drug Enforcement Administration (DEA) regulations for controlled substances is required.Broad knowledge of Laboratory instruments as HPLC, UPLC, Dionex, GC, Dissolution baths, TOC, FTIR, NIR, Automatic Titrator, UV Spectrophotometer, KF, among others.Write protocols for new instrument introduction – IQ, OQ, PQ, PVT, costing and troubleshooting/PM/Calibration.Author or guide end users in writing system operational procedures, work instructions, system guides templates and SOPs (Standard Operating Procedures).Comply with all environmental and quality trainings, procedures, guidelines, practices, current cGMP’s, permit conditions and internal notifications of any environmental or quality event.Perform any other job-related duties as required or that may arise in the future.

Requirements:

Education /Experience.

Bachelor degree in Science, Engineering or Computer Science from an accredited institution. Master’s degree is an added advantage. At least five (5) year of laboratory experience or systems validation in an FDA regulated environment is required.

Licenses and/or Certifications

CSQE Certified Software Quality Engineer from ASQ (American Society for Quality), preferred.Chemical Licensee, preferred.

Technical Competencies

Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways.Demonstrated analytical and problem-solving skills.Proven ability to teach others and transfer knowledge to end users. Able to work under pressure and self-starter.Ability to work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Regulatory (FDA) industry experience, familiarity with cGMPs, GAMP (Good automated manufacturing practice), Laboratory Equipment / Instrumentation C&Q practices (Commissioning & Qualification) and current to Pharmacopeias requirements, changes and modifications.Proven ability to learn new computer software/systems and laboratory instruments with minimum of instruction and general understanding of SLC (system life cycle) and CSV (computer validation system). Knowledge and experience with systems and validation processes.Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines, effective project management skills.Fully Bilingual, excellent oral and written communication in both English/Spanish languages.Skills in MS Office Suite applications of MS Project, Outlook, Word, and PowerPoint, and is skilled at performing data evaluation, formulas and metrics

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Analytical Services Scientist

Summary:

Will provide Analytical Technology expertise for Quality Control requirements within the introduction of new products to the Site, development / transfer / validation of analytical methodologies & technologies, instrumentation services & technologies, and the resolution of complex and critical analytical investigations. Will provide support to the QC Laboratory to ensure QC Systems maintenance. Participate as the Quality representative on steering committees, ad-hoc projects, introduction of new system, upgrades for the Quality Control Laboratory to ensure that requirements are identified and carried out following procedures and SLC (System Life Cycle processes) as required. Ensure the operational efficiency and excellence of the organization by designing, documenting and providing solutions to new business requirements, trends, and concepts appropriately through the latest technological paths. Will maintain Laboratory efficiency and capacity metrics. The incumbent understands the internal and external customer’s business requirements and business process management, and then translates them to process, system or software requirements.

Responsibilities:

Collaborate with functional areas to determine regulatory requirements, validation requirements, business & functional risks and work within cross-functional project teams in the development of validation deliverables or systems upgrades for Laboratory equipment and computer systems in Quality or within the Quality Systems.Generate, develop, evaluate, review and approval of Validation / Automation Documentation (validation plans, protocols and final reports), performance qualification, system life cycle approach to ensure compliance and regulatory requirements from the QC perspective.Coordination / direction and active participation in the validation of site laboratory equipment, facilities, utilities, processes and software in compliance with company policies, Federal Drug Administration (FDA) regulations, European current Good Manufacturing Practices (cGMP’s) and Good Automated Manufacturing Practice (GAMP) standards.Performs the method development, method validation, method transfer and method verification of new or existing products, guaranteeing implementation of a feasible and efficient process. Performs process Failure Mode and Effects Analysis (FMEA’s) and other process verification activities following current Regulatory Guidelines.Conduct, write and manage laboratory investigations.Must have excellent technical writing, experience on root cause analysis and CAPA plan determination.Maintenance of Investigations Metric to support Quality Council QC Metrics.Supports process activities to achieve a successful on time resolution of incidents and deviations and enhances quality and effectiveness of laboratory systems, including change control and Corrective Action /Preventive Action (CAPA) towards optimization laboratory processes to assure effectiveness, robustness, and compliance.Lead / Performs special project as assigned. Participate as a team leader or a member of the project teams where needed and help provide direction on future enhancements to the systems.Assist in solving problems during validation process, system upgrades or investigations and address or seek advice from SMEs (Subject Matter Experts) on issues such as deficiencies, deviations and change control.Administrate Quality Computer Systems and perform periodic review as required. Knowledge on Laboratory Information Management Systems (LIMS Vantage or LIMS Lab Ware) is desired. Full knowledge on Chromatographic Data Management System (CDMS) as Empower.Troubleshoot of methods, and or instruments as needed. Coordinate and manages outside services as required for calibration, maintenance, evaluations, quotes, etc. Perform calibration or maintenance as required. Manage, store, handle, dispose, label and inspect laboratory waste following Environmental Protection Agency (EPA), Environmental Quality Board (EQB) and site requirements procedures, guides and policy.Knowledge of Drug Enforcement Administration (DEA) regulations for controlled substances is required.Broad knowledge of Laboratory instruments as HPLC, UPLC, Dionex, GC, Dissolution baths, TOC, FTIR, NIR, Automatic Titrator, UV Spectrophotometer, KF, among others.Write protocols for new instrument introduction – IQ, OQ, PQ, PVT, costing and troubleshooting/PM/Calibration.Author or guide end users in writing system operational procedures, work instructions, system guides templates and SOPs (Standard Operating Procedures).Comply with all environmental and quality trainings, procedures, guidelines, practices, current cGMP’s, permit conditions and internal notifications of any environmental or quality event.Perform any other job-related duties as required or that may arise in the future.

Requirements:

Education /Experience.

Bachelor degree in Science, Engineering or Computer Science from an accredited institution. Master’s degree is an added advantage. At least five (5) year of laboratory experience or systems validation in an FDA regulated environment is required.

Licenses and/or Certifications

CSQE Certified Software Quality Engineer from ASQ (American Society for Quality), preferred.Chemical Licensee, preferred.

Technical Competencies

Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways.Demonstrated analytical and problem-solving skills.Proven ability to teach others and transfer knowledge to end users. Able to work under pressure and self-starter.Ability to work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Regulatory (FDA) industry experience, familiarity with cGMPs, GAMP (Good automated manufacturing practice), Laboratory Equipment / Instrumentation C&Q practices (Commissioning & Qualification) and current to Pharmacopeias requirements, changes and modifications.Proven ability to learn new computer software/systems and laboratory instruments with minimum of instruction and general understanding of SLC (system life cycle) and CSV (computer validation system). Knowledge and experience with systems and validation processes.Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines, effective project management skills.Fully Bilingual, excellent oral and written communication in both English/Spanish languages.Skills in MS Office Suite applications of MS Project, Outlook, Word, and PowerPoint, and is skilled at performing data evaluation, formulas and metrics

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Analytical Services Scientist

Summary:

Will provide Analytical Technology expertise for Quality Control requirements within the introduction of new products to the Site, development / transfer / validation of analytical methodologies & technologies, instrumentation services & technologies, and the resolution of complex and critical analytical investigations. Will provide support to the QC Laboratory to ensure QC Systems maintenance. Participate as the Quality representative on steering committees, ad-hoc projects, introduction of new system, upgrades for the Quality Control Laboratory to ensure that requirements are identified and carried out following procedures and SLC (System Life Cycle processes) as required. Ensure the operational efficiency and excellence of the organization by designing, documenting and providing solutions to new business requirements, trends, and concepts appropriately through the latest technological paths. Will maintain Laboratory efficiency and capacity metrics. The incumbent understands the internal and external customer’s business requirements and business process management, and then translates them to process, system or software requirements.

Responsibilities:

Collaborate with functional areas to determine regulatory requirements, validation requirements, business & functional risks and work within cross-functional project teams in the development of validation deliverables or systems upgrades for Laboratory equipment and computer systems in Quality or within the Quality Systems.Generate, develop, evaluate, review and approval of Validation / Automation Documentation (validation plans, protocols and final reports), performance qualification, system life cycle approach to ensure compliance and regulatory requirements from the QC perspective.Coordination / direction and active participation in the validation of site laboratory equipment, facilities, utilities, processes and software in compliance with company policies, Federal Drug Administration (FDA) regulations, European current Good Manufacturing Practices (cGMP’s) and Good Automated Manufacturing Practice (GAMP) standards.Performs the method development, method validation, method transfer and method verification of new or existing products, guaranteeing implementation of a feasible and efficient process. Performs process Failure Mode and Effects Analysis (FMEA’s) and other process verification activities following current Regulatory Guidelines.Conduct, write and manage laboratory investigations.Must have excellent technical writing, experience on root cause analysis and CAPA plan determination.Maintenance of Investigations Metric to support Quality Council QC Metrics.Supports process activities to achieve a successful on time resolution of incidents and deviations and enhances quality and effectiveness of laboratory systems, including change control and Corrective Action /Preventive Action (CAPA) towards optimization laboratory processes to assure effectiveness, robustness, and compliance.Lead / Performs special project as assigned. Participate as a team leader or a member of the project teams where needed and help provide direction on future enhancements to the systems.Assist in solving problems during validation process, system upgrades or investigations and address or seek advice from SMEs (Subject Matter Experts) on issues such as deficiencies, deviations and change control.Administrate Quality Computer Systems and perform periodic review as required. Knowledge on Laboratory Information Management Systems (LIMS Vantage or LIMS Lab Ware) is desired. Full knowledge on Chromatographic Data Management System (CDMS) as Empower.Troubleshoot of methods, and or instruments as needed. Coordinate and manages outside services as required for calibration, maintenance, evaluations, quotes, etc. Perform calibration or maintenance as required. Manage, store, handle, dispose, label and inspect laboratory waste following Environmental Protection Agency (EPA), Environmental Quality Board (EQB) and site requirements procedures, guides and policy.Knowledge of Drug Enforcement Administration (DEA) regulations for controlled substances is required.Broad knowledge of Laboratory instruments as HPLC, UPLC, Dionex, GC, Dissolution baths, TOC, FTIR, NIR, Automatic Titrator, UV Spectrophotometer, KF, among others.Write protocols for new instrument introduction – IQ, OQ, PQ, PVT, costing and troubleshooting/PM/Calibration.Author or guide end users in writing system operational procedures, work instructions, system guides templates and SOPs (Standard Operating Procedures).Comply with all environmental and quality trainings, procedures, guidelines, practices, current cGMP’s, permit conditions and internal notifications of any environmental or quality event.Perform any other job-related duties as required or that may arise in the future.

Requirements:

Education /Experience.

Bachelor degree in Science, Engineering or Computer Science from an accredited institution. Master’s degree is an added advantage. At least five (5) year of laboratory experience or systems validation in an FDA regulated environment is required.

Licenses and/or Certifications

CSQE Certified Software Quality Engineer from ASQ (American Society for Quality), preferred.Chemical Licensee, preferred.

Technical Competencies

Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways.Demonstrated analytical and problem-solving skills.Proven ability to teach others and transfer knowledge to end users. Able to work under pressure and self-starter.Ability to work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Regulatory (FDA) industry experience, familiarity with cGMPs, GAMP (Good automated manufacturing practice), Laboratory Equipment / Instrumentation C&Q practices (Commissioning & Qualification) and current to Pharmacopeias requirements, changes and modifications.Proven ability to learn new computer software/systems and laboratory instruments with minimum of instruction and general understanding of SLC (system life cycle) and CSV (computer validation system). Knowledge and experience with systems and validation processes.Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines, effective project management skills.Fully Bilingual, excellent oral and written communication in both English/Spanish languages.Skills in MS Office Suite applications of MS Project, Outlook, Word, and PowerPoint, and is skilled at performing data evaluation, formulas and metrics

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Analytical Services Scientist

Summary:

Will provide Analytical Technology expertise for Quality Control requirements within the introduction of new products to the Site, development / transfer / validation of analytical methodologies & technologies, instrumentation services & technologies, and the resolution of complex and critical analytical investigations. Will provide support to the QC Laboratory to ensure QC Systems maintenance. Participate as the Quality representative on steering committees, ad-hoc projects, introduction of new system, upgrades for the Quality Control Laboratory to ensure that requirements are identified and carried out following procedures and SLC (System Life Cycle processes) as required. Ensure the operational efficiency and excellence of the organization by designing, documenting and providing solutions to new business requirements, trends, and concepts appropriately through the latest technological paths. Will maintain Laboratory efficiency and capacity metrics. The incumbent understands the internal and external customer’s business requirements and business process management, and then translates them to process, system or software requirements.

Responsibilities:

Collaborate with functional areas to determine regulatory requirements, validation requirements, business & functional risks and work within cross-functional project teams in the development of validation deliverables or systems upgrades for Laboratory equipment and computer systems in Quality or within the Quality Systems.Generate, develop, evaluate, review and approval of Validation / Automation Documentation (validation plans, protocols and final reports), performance qualification, system life cycle approach to ensure compliance and regulatory requirements from the QC perspective.Coordination / direction and active participation in the validation of site laboratory equipment, facilities, utilities, processes and software in compliance with company policies, Federal Drug Administration (FDA) regulations, European current Good Manufacturing Practices (cGMP’s) and Good Automated Manufacturing Practice (GAMP) standards.Performs the method development, method validation, method transfer and method verification of new or existing products, guaranteeing implementation of a feasible and efficient process. Performs process Failure Mode and Effects Analysis (FMEA’s) and other process verification activities following current Regulatory Guidelines.Conduct, write and manage laboratory investigations.Must have excellent technical writing, experience on root cause analysis and CAPA plan determination.Maintenance of Investigations Metric to support Quality Council QC Metrics.Supports process activities to achieve a successful on time resolution of incidents and deviations and enhances quality and effectiveness of laboratory systems, including change control and Corrective Action /Preventive Action (CAPA) towards optimization laboratory processes to assure effectiveness, robustness, and compliance.Lead / Performs special project as assigned. Participate as a team leader or a member of the project teams where needed and help provide direction on future enhancements to the systems.Assist in solving problems during validation process, system upgrades or investigations and address or seek advice from SMEs (Subject Matter Experts) on issues such as deficiencies, deviations and change control.Administrate Quality Computer Systems and perform periodic review as required. Knowledge on Laboratory Information Management Systems (LIMS Vantage or LIMS Lab Ware) is desired. Full knowledge on Chromatographic Data Management System (CDMS) as Empower.Troubleshoot of methods, and or instruments as needed. Coordinate and manages outside services as required for calibration, maintenance, evaluations, quotes, etc. Perform calibration or maintenance as required. Manage, store, handle, dispose, label and inspect laboratory waste following Environmental Protection Agency (EPA), Environmental Quality Board (EQB) and site requirements procedures, guides and policy.Knowledge of Drug Enforcement Administration (DEA) regulations for controlled substances is required.Broad knowledge of Laboratory instruments as HPLC, UPLC, Dionex, GC, Dissolution baths, TOC, FTIR, NIR, Automatic Titrator, UV Spectrophotometer, KF, among others.Write protocols for new instrument introduction – IQ, OQ, PQ, PVT, costing and troubleshooting/PM/Calibration.Author or guide end users in writing system operational procedures, work instructions, system guides templates and SOPs (Standard Operating Procedures).Comply with all environmental and quality trainings, procedures, guidelines, practices, current cGMP’s, permit conditions and internal notifications of any environmental or quality event.Perform any other job-related duties as required or that may arise in the future.

Requirements:

Education /Experience.

Bachelor degree in Science, Engineering or Computer Science from an accredited institution. Master’s degree is an added advantage. At least five (5) year of laboratory experience or systems validation in an FDA regulated environment is required.

Licenses and/or Certifications

CSQE Certified Software Quality Engineer from ASQ (American Society for Quality), preferred.Chemical Licensee, preferred.

Technical Competencies

Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways.Demonstrated analytical and problem-solving skills.Proven ability to teach others and transfer knowledge to end users. Able to work under pressure and self-starter.Ability to work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Regulatory (FDA) industry experience, familiarity with cGMPs, GAMP (Good automated manufacturing practice), Laboratory Equipment / Instrumentation C&Q practices (Commissioning & Qualification) and current to Pharmacopeias requirements, changes and modifications.Proven ability to learn new computer software/systems and laboratory instruments with minimum of instruction and general understanding of SLC (system life cycle) and CSV (computer validation system). Knowledge and experience with systems and validation processes.Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines, effective project management skills.Fully Bilingual, excellent oral and written communication in both English/Spanish languages.Skills in MS Office Suite applications of MS Project, Outlook, Word, and PowerPoint, and is skilled at performing data evaluation, formulas and metrics

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Analytical Services Scientist

Summary:

Will provide Analytical Technology expertise for Quality Control requirements within the introduction of new products to the Site, development / transfer / validation of analytical methodologies & technologies, instrumentation services & technologies, and the resolution of complex and critical analytical investigations. Will provide support to the QC Laboratory to ensure QC Systems maintenance. Participate as the Quality representative on steering committees, ad-hoc projects, introduction of new system, upgrades for the Quality Control Laboratory to ensure that requirements are identified and carried out following procedures and SLC (System Life Cycle processes) as required. Ensure the operational efficiency and excellence of the organization by designing, documenting and providing solutions to new business requirements, trends, and concepts appropriately through the latest technological paths. Will maintain Laboratory efficiency and capacity metrics. The incumbent understands the internal and external customer’s business requirements and business process management, and then translates them to process, system or software requirements.

Responsibilities:

Collaborate with functional areas to determine regulatory requirements, validation requirements, business & functional risks and work within cross-functional project teams in the development of validation deliverables or systems upgrades for Laboratory equipment and computer systems in Quality or within the Quality Systems.Generate, develop, evaluate, review and approval of Validation / Automation Documentation (validation plans, protocols and final reports), performance qualification, system life cycle approach to ensure compliance and regulatory requirements from the QC perspective.Coordination / direction and active participation in the validation of site laboratory equipment, facilities, utilities, processes and software in compliance with company policies, Federal Drug Administration (FDA) regulations, European current Good Manufacturing Practices (cGMP’s) and Good Automated Manufacturing Practice (GAMP) standards.Performs the method development, method validation, method transfer and method verification of new or existing products, guaranteeing implementation of a feasible and efficient process. Performs process Failure Mode and Effects Analysis (FMEA’s) and other process verification activities following current Regulatory Guidelines.Conduct, write and manage laboratory investigations.Must have excellent technical writing, experience on root cause analysis and CAPA plan determination.Maintenance of Investigations Metric to support Quality Council QC Metrics.Supports process activities to achieve a successful on time resolution of incidents and deviations and enhances quality and effectiveness of laboratory systems, including change control and Corrective Action /Preventive Action (CAPA) towards optimization laboratory processes to assure effectiveness, robustness, and compliance.Lead / Performs special project as assigned. Participate as a team leader or a member of the project teams where needed and help provide direction on future enhancements to the systems.Assist in solving problems during validation process, system upgrades or investigations and address or seek advice from SMEs (Subject Matter Experts) on issues such as deficiencies, deviations and change control.Administrate Quality Computer Systems and perform periodic review as required. Knowledge on Laboratory Information Management Systems (LIMS Vantage or LIMS Lab Ware) is desired. Full knowledge on Chromatographic Data Management System (CDMS) as Empower.Troubleshoot of methods, and or instruments as needed. Coordinate and manages outside services as required for calibration, maintenance, evaluations, quotes, etc. Perform calibration or maintenance as required. Manage, store, handle, dispose, label and inspect laboratory waste following Environmental Protection Agency (EPA), Environmental Quality Board (EQB) and site requirements procedures, guides and policy.Knowledge of Drug Enforcement Administration (DEA) regulations for controlled substances is required.Broad knowledge of Laboratory instruments as HPLC, UPLC, Dionex, GC, Dissolution baths, TOC, FTIR, NIR, Automatic Titrator, UV Spectrophotometer, KF, among others.Write protocols for new instrument introduction – IQ, OQ, PQ, PVT, costing and troubleshooting/PM/Calibration.Author or guide end users in writing system operational procedures, work instructions, system guides templates and SOPs (Standard Operating Procedures).Comply with all environmental and quality trainings, procedures, guidelines, practices, current cGMP’s, permit conditions and internal notifications of any environmental or quality event.Perform any other job-related duties as required or that may arise in the future.

Requirements:

Education /Experience.

Bachelor degree in Science, Engineering or Computer Science from an accredited institution. Master’s degree is an added advantage. At least five (5) year of laboratory experience or systems validation in an FDA regulated environment is required.

Licenses and/or Certifications

CSQE Certified Software Quality Engineer from ASQ (American Society for Quality), preferred.Chemical Licensee, preferred.

Technical Competencies

Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways.Demonstrated analytical and problem-solving skills.Proven ability to teach others and transfer knowledge to end users. Able to work under pressure and self-starter.Ability to work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Regulatory (FDA) industry experience, familiarity with cGMPs, GAMP (Good automated manufacturing practice), Laboratory Equipment / Instrumentation C&Q practices (Commissioning & Qualification) and current to Pharmacopeias requirements, changes and modifications.Proven ability to learn new computer software/systems and laboratory instruments with minimum of instruction and general understanding of SLC (system life cycle) and CSV (computer validation system). Knowledge and experience with systems and validation processes.Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines, effective project management skills.Fully Bilingual, excellent oral and written communication in both English/Spanish languages.Skills in MS Office Suite applications of MS Project, Outlook, Word, and PowerPoint, and is skilled at performing data evaluation, formulas and metrics

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Analytical Services Scientist

Summary:

Will provide Analytical Technology expertise for Quality Control requirements within the introduction of new products to the Site, development / transfer / validation of analytical methodologies & technologies, instrumentation services & technologies, and the resolution of complex and critical analytical investigations. Will provide support to the QC Laboratory to ensure QC Systems maintenance. Participate as the Quality representative on steering committees, ad-hoc projects, introduction of new system, upgrades for the Quality Control Laboratory to ensure that requirements are identified and carried out following procedures and SLC (System Life Cycle processes) as required. Ensure the operational efficiency and excellence of the organization by designing, documenting and providing solutions to new business requirements, trends, and concepts appropriately through the latest technological paths. Will maintain Laboratory efficiency and capacity metrics. The incumbent understands the internal and external customer’s business requirements and business process management, and then translates them to process, system or software requirements.

Responsibilities:

Collaborate with functional areas to determine regulatory requirements, validation requirements, business & functional risks and work within cross-functional project teams in the development of validation deliverables or systems upgrades for Laboratory equipment and computer systems in Quality or within the Quality Systems.Generate, develop, evaluate, review and approval of Validation / Automation Documentation (validation plans, protocols and final reports), performance qualification, system life cycle approach to ensure compliance and regulatory requirements from the QC perspective.Coordination / direction and active participation in the validation of site laboratory equipment, facilities, utilities, processes and software in compliance with company policies, Federal Drug Administration (FDA) regulations, European current Good Manufacturing Practices (cGMP’s) and Good Automated Manufacturing Practice (GAMP) standards.Performs the method development, method validation, method transfer and method verification of new or existing products, guaranteeing implementation of a feasible and efficient process. Performs process Failure Mode and Effects Analysis (FMEA’s) and other process verification activities following current Regulatory Guidelines.Conduct, write and manage laboratory investigations.Must have excellent technical writing, experience on root cause analysis and CAPA plan determination.Maintenance of Investigations Metric to support Quality Council QC Metrics.Supports process activities to achieve a successful on time resolution of incidents and deviations and enhances quality and effectiveness of laboratory systems, including change control and Corrective Action /Preventive Action (CAPA) towards optimization laboratory processes to assure effectiveness, robustness, and compliance.Lead / Performs special project as assigned. Participate as a team leader or a member of the project teams where needed and help provide direction on future enhancements to the systems.Assist in solving problems during validation process, system upgrades or investigations and address or seek advice from SMEs (Subject Matter Experts) on issues such as deficiencies, deviations and change control.Administrate Quality Computer Systems and perform periodic review as required. Knowledge on Laboratory Information Management Systems (LIMS Vantage or LIMS Lab Ware) is desired. Full knowledge on Chromatographic Data Management System (CDMS) as Empower.Troubleshoot of methods, and or instruments as needed. Coordinate and manages outside services as required for calibration, maintenance, evaluations, quotes, etc. Perform calibration or maintenance as required. Manage, store, handle, dispose, label and inspect laboratory waste following Environmental Protection Agency (EPA), Environmental Quality Board (EQB) and site requirements procedures, guides and policy.Knowledge of Drug Enforcement Administration (DEA) regulations for controlled substances is required.Broad knowledge of Laboratory instruments as HPLC, UPLC, Dionex, GC, Dissolution baths, TOC, FTIR, NIR, Automatic Titrator, UV Spectrophotometer, KF, among others.Write protocols for new instrument introduction – IQ, OQ, PQ, PVT, costing and troubleshooting/PM/Calibration.Author or guide end users in writing system operational procedures, work instructions, system guides templates and SOPs (Standard Operating Procedures).Comply with all environmental and quality trainings, procedures, guidelines, practices, current cGMP’s, permit conditions and internal notifications of any environmental or quality event.Perform any other job-related duties as required or that may arise in the future.

Requirements:

Education /Experience.

Bachelor degree in Science, Engineering or Computer Science from an accredited institution. Master’s degree is an added advantage. At least five (5) year of laboratory experience or systems validation in an FDA regulated environment is required.

Licenses and/or Certifications

CSQE Certified Software Quality Engineer from ASQ (American Society for Quality), preferred.Chemical Licensee, preferred.

Technical Competencies

Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways.Demonstrated analytical and problem-solving skills.Proven ability to teach others and transfer knowledge to end users. Able to work under pressure and self-starter.Ability to work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Regulatory (FDA) industry experience, familiarity with cGMPs, GAMP (Good automated manufacturing practice), Laboratory Equipment / Instrumentation C&Q practices (Commissioning & Qualification) and current to Pharmacopeias requirements, changes and modifications.Proven ability to learn new computer software/systems and laboratory instruments with minimum of instruction and general understanding of SLC (system life cycle) and CSV (computer validation system). Knowledge and experience with systems and validation processes.Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines, effective project management skills.Fully Bilingual, excellent oral and written communication in both English/Spanish languages.Skills in MS Office Suite applications of MS Project, Outlook, Word, and PowerPoint, and is skilled at performing data evaluation, formulas and metrics

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

QA Specislist II

Description:

The Quality Analyst is responsible for resolution of issues with suppliers (investigations and corrective actions), maintenance of supplier status, evaluation and closure of supplier change notifications, supplier scorecards and SQA reports.

Responsibilities:

Coordinates resolution of problem relating to quality and performance of purchased materials with suppliers and Manufacturing Quality Assurance.The incumbent monitors and manages implementation of new and existing processes that ultimately impact vendor product quality assurance.Establish and document contact with suppliers concerning quality issues/concerns (i.e. nonconformity, deviation, defect report, waivers, etc.).Perform assessment of supplier change notification (SCN) of incoming material. Monitor supplier change notification review through Plant to ensure a timely completion.Evaluates Specification Acceptance Letter exception and assess need for elevation to area management, as needed.Updates and maintains the System Application Product (SAP) system with current specification date, approval of supplier sites and/or purchasing control.Interfaces with and maintains cooperative relationships with plant departments to assure the total integrity and usability of incoming materials.Serves as an effective liaison and maintains a cooperative relationship with other Quality areas, Plant departments, Bioresearch Center counterparts, and TPMs as needed.Assists section with the follow-up and close out of the management reviews action items upon their implementation.Ensures that all quality goals are met, and all practices and procedures comply with applicable policies and regulations for the Quality areas under his/her responsibility.The Quality Analyst is responsible for resolution of issues with suppliers (investigations and corrective actions), maintenance of supplier status, evaluation and closure of supplier change notifications, supplier scorecards and SQA reports.

Qualifications:

Bachelor’s degree in Natural Sciences, Biology, Chemistry or Engineering.Quality related work in the pharmaceutical or medical device Health Care Organization. Total combined minimum years of experience required - 2 years.Key Stakeholders: Suppliers, Purchasing, IQA, Materials Management, TPM's, Technical groups, Manufacturing, Quality Assurance, Compliance, Validation, etc.Good problem solving and analytical skillsGood interpersonal relations/communications skillsGood verbal and written communicationGood negotiation skillsQuality related work in the pharmaceutical or medical device Health Care Organization. Total combined minimum years of experience required - 5 years.Technical Skills:Good verbal and written communication.Good problem solving and analytical skills.Good interpersonal relations/communications skills.Good negotiation skills.Good analytical skills.Supplier Management Experience.Must be fully bilingual (English / Spanish).Must be proficient using MS Windows and Microsoft Office applications.Experience in pharmaceutical industry.Preference experience in incoming quality area.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less