Validation & Engineering Group, Inc. (V&EG) 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 Quality Control
SUMMARY
Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
FUNCTIONS
-Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
-Resolve technical issues and troubleshoot for assays as necessary
-Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
-Manage existing and/or develop and implement new programs, processes and methodologies.
-Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
-Approve lab investigations, Lead audit teams
-May serve as subject matter expert to develop technical training.
-May perform routine work in a specific area of responsibility as necessary.
-Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
-May interact with regulatory agencies regarding area(s) of responsibility including written responses.
-May resolve issues with outside resources.
-Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.
EDUCATION
-Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR
COMPETENCIES/SKILLS
-Excellent communication skills, facilitation and presentation skills.
-Excellent technical writing skills.
-Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.
-Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
-Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
-Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
-Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
-Knowledge of pharmaceutical processes.
-Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
-Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
-Extensive knowledge and application of GMPs/CFRs.
-Ability to evaluate compliance issues.
-Skill in evaluating and documenting according to Company and various guidelines.
-Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
-Advanced scientific data analysis and interpretation skills.
-Advanced skills in solving complex problems.
-Advanced data trending and evaluation.
-Strong skill in working independently and to effectively interact with various levels.
-Ability to interact with regulatory agencies both orally and in writing.
-Initiate, coordinate and lead cross functional teams.
-Excellent skill in leading, motivating, influencing, and negotiating.
ATRIBUTES:
• Scientific Data Analysis
• Strong Technical Writing (English and Spanish) mainly focuses
• Strong knowledge in Microsoft Excel as a Tool for Data Analysis
• Good Communication skills
• Project Management
• Knowledge in Computer System and Method Validation (Experience preferable)
• Strong knowledge and experience with quality process management
• Basic Knowledge on equipment preventive maintenance and troubleshooting
• Agile on prioritization of critical tasks
• Ability to develop inspection or qualification protocols in a short timeframe period.
• Strong negotiation skills
Validation & Engineering Group, Inc. (V&EG) 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 Quality ControlSUMMARY
Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
FUNCTIONS
-Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
-Resolve technical issues and troubleshoot for assays as necessary.
-Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
-Manage existing and/or develop and implement new programs, processes and methodologies.
-Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
-Approve lab investigations, Lead audit teams.
-May serve as subject matter expert to develop technical training.
-May perform routine work in a specific area of responsibility as necessary.
-Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
-May interact with regulatory agencies regarding area(s) of responsibility including written responses.
-May resolve issues with outside resources.
-Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.
EDUCATION
-Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR
-Associates + 8 years of directly related experience OR
COMPETENCIES/SKILLS
-Understand, support and demonstrate the company values.
-Excellent communication skills, facilitation and presentation skills.
-Excellent technical writing skills.
-Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.
-Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
-Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
-Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
-Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
-Knowledge of pharmaceutical processes.
-Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
-Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
-Extensive knowledge and application of GMPs/CFRs.
-Ability to evaluate compliance issues.
-Skill in evaluating and documenting according to Company and various guidelines.
-Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
-Advanced scientific data analysis and interpretation skills.
-Advanced skills in solving complex problems.
-Advanced data trending and evaluation.
-Strong skill in working independently and to effectively interact with various levels.
-Ability to interact with regulatory agencies both orally and in writing.
-Initiate, coordinate and lead cross functional teams.
-Excellent skill in leading, motivating, influencing, and negotiating.
Validation & Engineering Group, Inc. (V&EG), a Pinnaql Company, is a leading professional services firm that provides engineering and regulatory compliance 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:
Talent Acquisition Specialist IThis is an on-site position at Guaynabo, PR.Description:
Handle hiring requests including:Collecting the hiring demands: Working alongside the Sales Department to finalize the hiring demands & JDs as well as fulfillment timeline.Job Description: Develop Job Descriptions in line with Human ResourcesRequisitions: Manage requisition entry into Applicant Tracking System (ATS)Job Postings: Post jobs via LinkedIn and other career sitesATS: Manage and update ATS as the source of truth for the talent acquisition processSourcing: Search for passive and active candidates and approach for the right opening jobs.Selection: phone interview, schedule interview, assign technical test, joining interview, prepare candidate assessment form, etc.Hiring Process: In conjunction with Human Resources, collaborate on the hiring process & progress to ensure good candidate experience.Offer: communicate verbal offer and collaborate with Human resources to prepare the offer, call the candidate to discuss the offer and relevant information, be prepared to negotiate during the process, if necessary, follow up with the candidate until the final decision is made, and update newcomer information on the portal.Maintain consistent communication with candidates throughout their candidacy process. Deliver updates including but not limited to rejection notification.Advertise jobs openings to attract candidates.Participate in job fairs to maintain a robust pool of candidates.Manage and exceed Talent Acquisition metrics and expectations developing relevant reports: weekly, monthly, and quarterly.Proactively build passive candidate pipeline to enlarge the Talent Pool.Qualifications:
Bachelor’s degree in human resources, related degree or equivalent work experience.At least 3 years of experience managing all phases of the recruitment and hiring process.At least 3 years of experience recruiting for the life sciences manufacturing industry (Pharma, Medical Devices or Biotechnology).At least 3 years of experience recruiting hourly professional consulting positions.At least 3 years of experience working with Excel, Word, Power Point, MS Outlook and Share Point.Experience working with Applicant Tracking Systems, preferably Clear Company.A high level of professionalism and discretion, this role will be have access to confidential employee data.A genuinely pro-active and helpful attitude, with a strong work ethic and excellent attention to details.Initiative and confidence to work autonomously when required.Ability to handle and effectively prioritize a diverse and changing workload.Strong communication skills with ability to speak to a wide range of people at all levels, including clients, company leadership, sales, and operations.Ability to work under pressure and in a fast-paced environment.Ability to quickly adapt to changes.Organization skills.Excellent verbal and written communication skills in both English and Spanish. Read LessValidation & Engineering Group, Inc. (V&EG) 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:
Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 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.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) 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:
Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 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.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) 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:
Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 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.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) 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:
Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 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.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) 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:
Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 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.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) 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:
Process Development Technician
Purpose Statement: Supports development of capable processes and ensures efficient and effective transfer of products into production. Contributes with Process Development engineers, scientists, and/or teams in the development and analysis of processes and equipment. This position requires high independence and knowledge on automated manufacturing equipment.
Key Responsibilities:
Executes functional deliverables associated with Process Development and Technology Development projects.Assesses process capabilities, innovates, and implements process improvements on complex processes.Work with engineers and internal/external vendors to maintain/fix/calibrate/qualify manufacturing equipment.Support testing or manufacture of prototypes/materials with minimal engineering guidance.Organize and document testing data and prepare reports/documentation to communicate results.Applies technical knowledge to support, design, and the development of processes, procedures, tooling and automation.Typically makes important technical contributions as part of an extended team.Work cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain and Marketing to ensure project success.Identifies problems and proposes solutions to technical challenges. Independently solves basic issues within functional area.Supports, researches, and evaluates new technologies within functional area. Remains knowledgeable of available technologies within functional area. May identify new applications for established technologies.Familiarity with a variety of technologies and equipment used in the industry to carry out manufacturing processes, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, general experience with automated equipment (PLC/Servos/Pneumatics/ Sensors), etc.Ability to collaborate with other engineers, scientists, and production personnel to achieve manufacturing process development objectives and solve problems effectively.Train others on new product processes and procedures.Required Qualifications:
Associate’s degree or equivalent combination of education/work experience1-2 years of related experienceProven record of working closely and successfully with manufacturing and process development engineersBasic understanding of medical device documentation requirementsGreat attitude and strong desire to learn new skillsPreferred Qualifications:
Manufacturing backgroundMedical Device industry experienceGood technical writing skillsAbility to read electrical prints and schematics Read LessValidation & Engineering Group, Inc. (V&EG) 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:
Validation Engineer – Process Development
Purpose Statement
Engineer, Validations: Develops and reviews documentation and procedures, and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering.
Key Responsibilities:
Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures.Design and develop in-process and receiving quality systems for new processes and components.Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. Define gages, tools and equipment for the test methods developed.Generate manufacturing instructions for new processes being developed.Work cross-functionally with other departments to accomplish PD tasks.Qualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 - 5years of experience in direct pharmaceutical, medical device or biotechnology industries.Experience in medical devices operations.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).Strong knowledge (according to related area). Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read Less