Validation Engineer
A validation and quality assurance provider is looking to hire Validation Engineers for their Greenbush, NY project site experience in Drug Product facilities to qualify a new commercial fill finish line. If the candidate has Veeva Vault and/or ValGenesis experience, this is a plus. The ideal candidate will have firsthand experience in qualifying, generating, and executing validation activities for critical pharmaceutical processing and containment systems, with a proven track record in the cadence of regulatory standards (FDA, GMP, GxP). This role requires strong technical writing, cross-functional collaboration, and a disciplined approach to data integrity and quality. Experience working in a CDMO facility is also a plus. This is a long-term contracting assignment. Out of state candidates will be provided Food: $70/day (no receipts required) guaranteed. Room and Board: (specific hotels in the area established) Mileage: National rate 72.5 cents per mile Hourly rate is $55.00 to $60.00. Key Responsibilities Qualify, validate, and execute installation, operational, and performance qualifications (IQ/OQ/PQ/EMPQ) for drug product processing equipment and containment systems. Support validation activities for Isolators, DeNesters, E-Beam sterilization systems, Lyophilizers, Capper/Stopper lines, Glove Boxes, and associated process equipment (Skan equipment and related instrumentation). Develop, review, and execute validation Master Plans, Validation Plans, URS/FS, Risk Assessments, IQ/OQ/PQ protocols, SOPs, and Validation Summary Reports (VSRs) in compliance with GMP, FDA 21 CFR Part 11, Annex 11, ICH guidelines, and GxP. Experience with Change Control process of Clean Utilities (Gases, WFI, Vacuum, HVAC) Conduct Cleaning Validation (VHP) for equipment used in aseptic drug product manufacturing. Plan and perform EMPQ (Environmental Monitoring Performance Qualifications) activities. Generate and maintain comprehensive documentation to support regulatory submissions and inspections, including traceability matrices and CAPA integration. Collaborate with Manufacturing, QA, Engineering, QC, and IT to ensure data integrity, equipment readiness, and ongoing compliance. Ensure calibration, maintenance, and performance verification activities align with validated state and GMP expectations. Experience with Deviation generation and remediation. Required Qualifications Bachelor’s degree in biomedical engineering, Chemical Engineering, Biotech, or related life sciences field; advanced degree preferred. 5 years of validated experience in a GMP drug product environment, with firsthand involvement in qualifying isolators, DeNesters, E-Beam, Lyophilizers, capper/stopper lines, glove boxes, and Skan equipment. Demonstrated proficiency in IQ/OQ/PQ/EMPQ development, risk assessments (IQ/OQ/PQ), and Validation Master Planning. Experience with temperature mapping and environmental monitoring systems as applicable to sterile and cleanroom facilities. Familiarity with cGMP regulations (FDA), EMA guidelines, and ICH/GxP standards; understanding of 21 CFR Part 11 and Annex 11 for electronic records/electronic signatures. Excellent technical writing and documentation skills; ability to produce clear, concise, audit-ready reports. Experience coordinating with cross-functional teams and managing multiple projects simultaneously; strong problem-solving and decision-making abilities. Willingness to work on-site in East Greenbush, NY; ability to work flexibly to meet project timelines. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law. Allen Mudalel (610) 828-7356 [email protected] 515 Grove St. Suite 3G • Haddon Heights, NJ 08035 • jsginc.com
