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:
Jr ChemistKey Responsibilities:
1. Quality Control & Analysis
Perform chemical, physical, and instrumental testing on raw materials, in-process samples, and finished products.Use analytical techniques such as HPLC, GC, FTIR, UV-Vis spectroscopy, and titration to ensure material conformance to specifications.2. Documentation & Compliance
Accurately document all results and findings in compliance with cGMP, ISO 13485, FDA, and other regulatory standards.Prepare and review lab reports, Certificates of Analysis (CoA), and batch records.3. Method Development & Validation
Assist in developing, optimizing, and validating analytical methods for raw materials and finished products.Perform method transfers and support process validation activities.4. Instrument Calibration & Maintenance
Calibrate, maintain, and troubleshoot laboratory instruments to ensure accurate and reliable results.Follow established protocols for preventive maintenance and equipment qualification.5. Collaboration & Continuous Improvement
Work closely with R&D, Quality Assurance, and Production teams to address quality issues and support product development.Participate in investigations of non-conformances and implement corrective/preventive actions.Contribute to process improvements, cost reduction, and efficiency initiatives in the laboratory.6. Regulatory Support
Provide technical support during audits and regulatory inspections.Stay updated on industry standards, guidelines, and regulations affecting raw material and finished product testing.Qualifications:
1. Education
Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, or a related field.2. Experience
Minimum 2-4 years of experience in a Finished Product Lab or Raw Material Lab in the Medical Device, Pharmaceutical, or related industry.Experience with cGMP, ISO 13485, and FDA regulations.3. Technical Skills
Proficiency in analytical techniques such as HPLC, GC, FTIR, UV-Vis, and wet chemistry methods.Strong knowledge of material characterization and quality control principles.Experience with Laboratory Information Management Systems (LIMS) is a plus.4. Soft Skills
Strong analytical and problem-solving skills.Excellent communication and documentation abilities.Ability to work both independently and as part of a team. 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:
Lab Tech IIPosition DescriptionThe selected candidate will perform routine analytical testing to support on-site wastewater treatment operations and ensure compliance with local and state regulatory requirements. This role requires the ability to interpret analytical data, coordinate sample testing, and accurately document results using computerized systems. The position is based in laboratory areas and involves close collaboration within a team environment.
Key ResponsibilitiesPerform routine analytical testing in support of on-site wastewater treatment operations.
Ensure compliance with local and state environmental requirements.
Coordinate sample testing activities and input analytical data into computer spreadsheets and laboratory systems.
Review and verify analytical data related to finished products and raw materials.
Operate analytical laboratory equipment, including analytical balances, total carbon analyzers, spectrophotometers, and pH meters.
Interpret test results and support basic data analysis and troubleshooting.
Follow laboratory safety, quality, and documentation standards.
Support increased workload and volume demands as required by business needs.
Required QualificationsBachelor’s degree or Associate degree in Chemistry or a related chemical field.
Minimum of 2 years of experience in a pharmaceutical chemical laboratory environment.
Strong laboratory skills; experience in wastewater testing is preferred but not required.
Experience reviewing analytical data for raw materials and finished products.
Proficiency in operating analytical laboratory equipment.
Ability to understand, read, and write English.
Strong problem-solving skills and attention to detail.
Computer proficiency, including data entry and spreadsheet use.
Effective verbal and written communication skills.
Background in chemical analysis (microbiology experience not required).
Work Environment & ScheduleWork environment: Laboratory areas; team-based setting.
Shift: Primarily second shift; must be flexible to work first or second shift as business needs vary.
Schedule may vary from Monday–Friday or Tuesday–Saturday.
Overtime is required based on business needs, including approximately one weekend per month.
Additional InformationOn-site position; remote work is not available.
Relocation assistance is not provided; candidates must already be local.
No travel required.
No work with toxins.
Interview process: One interview round conducted via Microsoft Teams.
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:
Environmental Cleaning Specialist
Summary:
Perform microbial control cleaning procedures that comply with current Good Manufacturing Practices (cGMP) and regulatory guidelines which include documentation of work procedures frequently audited by the FDA and other regulatory agencies.
Responsibilities:
•Perform cross contamination cleaning methods in areas that require microbial control.
•Complete cGMP documentation of training or cleaning performed on paper and electronic devices.
•Prepare cleaning solutions based on cGMP regulated mixing instructions.
•Perform microbial control cleaning techniques on walls, ceiling and floors based on cGMP regulated cleaning frequencies.
•Complete preventive maintenance work orders to meet cGMP cleaning requirements.
•Follow specific gowning procedures and performs cGMP entrance and exit procedures for controlled environments.
•Operate bailing and compacting equipment and various types of hand held battery and electric cleaning equipment.
•Operate various types of battery and electric walk behind or ride-on floor cleaning equipment.
•Perform safety and preventive maintenance inspections on housekeeping power equipment and small tools and wears approved PPE.
•Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.
•Supply materials and gowning to manufacturing areas.
•Follow Good Documentation Practices GDPs.
Qualifications
•Minimum of High School Diploma or GED. AD and or BD in sciences is highly preferred.
•Able to read and comprehend written information to include Corporate Quality Documents, Divisional Operating Procedures, Departmental Operating Procedures and Safety Guidelines.
•Comply with cGMP, regulatory guidelines and able to write legibility in English and complete accurate and legible written records in compliance with cGMP when documenting work performed, on paper documents and electronic devices auditable by regulatory agencies.
•Ability to operate a computer to complete required compliance; technical training.
•Capable to learn and perform cleaning techniques to meet regulatory requirements.
•Work alone or as a team member sharing responsibility and work tasks.
•Able to perform all cleaning specialist job functions.
Performs industrial cleaning of production areas. May include mixing chemical solutions/solvents to clean necessary work areas.
Skills & Experience required for this position
•Available to work 1st, 2nd 3rd shift – OT, weekends, Holiday
•Team works oriented
•Punctuality and assistance is required
•Experience Level = 1-3 Years
What is a nice to have (but not required)
•Team/Inspection & production areas
•Cleaning areas grade B
•Daily Work Schedule Expectations ALL candidates must be available to work
•Based on Manufacturing needs
•Tuesday to Saturday
•Sunday to Thursday
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:
QC Chemist ScientistThe position will support the organization with initial compliance and ongoing preparation, testing, monitoring and reviewing of conformance to established quality control process and standards for manufacturing and production.
Perform evaluation of internal controls, and review of documentation related to compliance with external and internal safety, quality, and regulatory standards.Conducts moderately complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.Perform analyses in a chemistry environment within defined procedures and practices.Prepare documentation of the testing/analysis and obtained results.Document, calculate, verify, approves and/or report results of the analysis in accordance with prescribed lab procedures and systems.Support and/or coordinate sample analysis and maintain a schedule plan to ensure goals and objectives are met within the prescribed time frame.Qualifications:
Bachelor's degree in Chemistry, Biology, Life Sciences or other related field.Minimum of 5 years position related experience.Excellent interpersonal oral and written communication skills.Proficiency in the English language.Available to work on different shifts.Licensed preferred.Experience with quality system, stability specific laboratory systems and laboratory chromatographic data acquisition systems.Experience with Microsoft Word and Excel. 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:
Engineering Technical Leads ETLsProject 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. 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:
MEC Laboratory Tech I
Summary:
Perform microbiological testing required for water used in the manufacturing process, raw materials, in process samples and final product following specifications. Perform microbiological testing such as bioburden and endotoxin to water samples used in the product manufacturing process and to the final product. Perform in process product testing such as bioburden, contamination check and endotoxin. Perform all the facilities and utilities environmental monitoring using Climet, RCS, and surface sampling. Perform gowning sampling as part of routine program and for qualification/routine requirements. Follow Good Manufacturing Practices (cGMP), safety rules and Good Laboratory Practices (GLP). Provide support to the manufacturing area during filling process.
Responsibilities:
• Responsible for performing the environmental monitoring to the manufacturing area and laboratory test (Raw materials, in process sample and finished product) following the established parameters ( policies, FDA, cGMP) and applicable regulations without impact to the manufacturing cycle or laboratory workflow.
• Document The results of the test and analysis performed accurately.
• Perform maintenance to laboratory equipment.
• Identify, collect, and submit samples to the MEC laboratory.
• Assure that all samples are collected, tested, and authorized as per schedule and following applicable procedure.
• Assist the MEC Laboratory Service, to maintain adequate inventory of materials, reagents, culture media, reference material, and general-purpose material for the operation of the Environmental Control Laboratory.
• Complete training and certifications on time as established in the training curriculums.
• Control and management for the disposal of domestic, biomedical, and hazardous wastes of the MEC area as applicable, ensuring compliance with Local and Federal regulations following the procedures and policies of the plant, division, and the corporation.
• Participate and promote continuous improvement to the Environmental health and safety (EH&S).
Qualifications:
Associate degree in Natural science with major in Biology, Chemistry, Microbiology and or Minimum of One year of experience in the Pharmaceutical industry or equivalent in a microbiology laboratory.
Skills & Experience required for this position
Nice to have (but not required)
Previous experience preferred but not required
In what type of environment would this individual be working?
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:
Process Development ScientistSUMMARY
To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
FUNCTIONS
-Conceives and designs, executes or evaluates, and interprets experimental strategies.
-Provides input to new processes to generate robust and reliable data.
-Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
-Designs, monitors or conducts experimental strategies with general guidance from supervisor.
-Provides data analysis and interpretation, and assesses impact of the data on the project.
-Keeps current in field of scientific expertise and areas relevant to their function.
-Monitors field of expertise, including literature and technology development, and communicates relevant observations.
-May introduce advanced scientific methods.
-Develops and implements new and novel protocols to address specific issues.
-May represent the department on project teams under supervision of a senior scientific staff member.
-May initiate productive collaborations within and outside of the department or company.
-Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
-Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
-Participates in external scientific community.
-May assume lead role in department-wide support efforts such as safety, recruiting and committees.
-May develop supervisory and mentoring skills.
-Develops and follows timelines for completing project teamwork.
EDUCATION
-Doctorate OR
-Master's + 2 years of Scientific experience OR
-Bachelors + 4 years of Scientific experience.
COMPETENCIES/SKILLS
-Advanced scientific analysis and troubleshooting skills. Advanced laboratory work skills.
-Ability to motivate and/or supervise the activities of others.
-Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
-Must have demonstrated skills and competencies in the following areas: Verbal communication, Written communication including technical writing skills, negotiation and conflict resolution. Analytical problem solving
-Ability to be flexible and manage change.
-Computer literacy (Windows environment: Word, Excel, Power Point).
-Skills requiring the application of scientific theory.
-Creative skills in the design and performance of scientific experiments and interpretation of results.
-Strong knowledge of cGMP
PREFERRED QUALIFICATIONS
1. Automated Visual Inspection (AVI) Expertise (Key Differentiator - Highly Desired)
• Direct experience with automated visual inspection systems, such as:
o Machine vision–based inspection platforms
o Camera systems, lighting optimization, optics
o Image acquisition and defect detection logic
• Knowledge of AVI system qualification and validation:
o IQ/OQ/PQ
o Performance qualification using defect kits
• Experience developing or supporting:
o Inspection recipes
o Defect libraries and defect standards
o Sensitivity and false reject optimization
• Familiarity with manual vs automated inspection correlation
2. Data, Statistics & Digital Skills (Preferred)
• Strong statistical background, including:
o Sampling plans (AQL, zero acceptance, etc.)
o Inspection capability studies
o Measurement system analysis (MSA)
• Experience with data analysis tools:
o JMP, Minitab, Python, or equivalent
• Comfort working with large inspection datasets to:
o Trend defect rates
o Support process improvements
o Drive inspection strategy decisions
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:
Calibration Documentation & Planning Specialist
Job DescriptionWe are seeking a Calibration Documentation & Planning Specialist to support calibration planning and documentation activities.
This role will focus on planning coordination and calibration documentation review. The specialist will work closely with internal teams and external vendors to ensure calibration activities are properly planned, tracked, and documented in compliance with site and regulatory requirements.
Key ResponsibilitiesSupport calibration planning activities for a group, dedicating approximately two (2) days per week to planning and scheduling.
Perform documentation review and management for calibrations executed by external vendors, dedicating approximately three (3) days per week.
Review, verify, and organize calibration records, certificates, and supporting documentation.
Ensure calibration documentation meets internal quality standards and regulatory expectations.
Track calibration activities, deviations, and documentation status.
Work within Maximo (CMMS) to manage calibration records, planning, and documentation workflows.
Interface with vendors, quality, and engineering teams as needed to resolve documentation issues.
Required QualificationsMinimum 5 years of experience in calibration-related environments (pharmaceutical, biotech, or regulated manufacturing).
Strong background in calibration concepts and processes.
Proven experience with calibration documentation and planning.
Experience working with Maximo or similar CMMS systems.
Familiarity with GMP and regulated documentation practices.
Strong organizational skills and attention to detail.
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:
Project Coordinator – Downstream BiologicsProject Duration: 4–6 months, with potential for extension or future projects at the site.
Role Summary:
We are seeking a self-sufficient Project Coordinator to support a downstream biologics validation project at a cGMP manufacturing site. The ideal candidate has hands-on experience scheduling engineering activities across multiple departments and suppliers.
Key Responsibilities:
Coordinate project schedules, deliverables, and communications across multiple equipment vendors, validation service providers, and stakeholder departments.Develop and maintain daily, weekly, and monthly schedules. Tracks ongoing progress, identifies risks, and communicates clear status updates.Collaborate with Engineering, Manufacturing, Quality, and Automation teams to ensure activities are aligned, dependencies are managed, and timelines are maintainedAttends project update meetings as neededRequired Experience
Bachelor’s degree in Engineering, Life Sciences, or business administration.5+ years experience in project management.Ability to work on-site and operate independently.Excellent documentation and communication skills.Preferred:
Prior support of commercial manufacturing, technical transfer, or validation efforts.Availability for project start within short notice. 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 EngineerProject Duration: 4–6 months, with potential for extension or future projects at the site.
Role Summary:
We are seeking a self-sufficient Validation Engineer to support a downstream biologics validation project at a cGMP manufacturing site in Puerto Rico. The ideal candidate has hands-on experience validating downstream processes, equipment, and instruments and can manage validation activities with minimal supervision.
Key Responsibilities:
Execute and manage downstream validation activities (IQ/OQ/PQ, PPQ support).Validate downstream equipment including autoclaves, environmental chambers, chromatography, filtration/UF-DF, centrifuges, formulation systems, and lyophilizers.Validate analytical and process instruments (e.g., HPLC, in-line sensors).Author and execute validation protocols and reports in compliance with cGMP/FDA requirements.Collaborate with Engineering, Manufacturing, Quality, and Automation teams.Support deviations, change controls, and audit readiness as needed.Required Experience:
Bachelor’s degree in Engineering or Life Sciences.5+ years validation experience in biologics/pharmaceutical manufacturing.Strong hands-on experience with downstream process and equipment validation.Ability to work on-site and operate independently.Excellent documentation and communication skills.Preferred:
Prior support of commercial manufacturing or PPQ.Availability for project start within short notice. Read Less