Project Validation Engineer

Responsibilities

• Develop and review CQV documentation including URS, DQ, FAT, SAT, IQ, OQ, PQ protocols and reports
• Prepare and maintain traceability matrices, risk assessments (FMEA, impact assessments), and compliance documentation
• Coordinate with engineering, quality, automation, and construction teams to align validation schedules and readiness
• Lead or support CQV activities for clean utilities (WFI, clean steam, pure steam, clean compressed air, nitrogen, RO systems) and filling line equipment (isolators, RABS, vial washers, depyrogenation tunnels, filling machines, lyophilizers)
• Perform field verification of P&IDs, wiring diagrams, loop checks, and calibration activities
• Execute IQ, OQ, PQ protocols, review data, and resolve deviations or non-conformances
• Collaborate with equipment vendors during FAT/SAT and site acceptance testing
• Support change control, deviation documentation, and audit readiness of all validation deliverables
• Maintain compliance with cGMP, ICH, and corporate validation standards throughout the project lifecycle

Qualifications

• Bachelor’s degree in Engineering or Life Sciences (Chemical, Mechanical, or Biomedical Engineering preferred)
• 3–5 years of experience in a GMP pharmaceutical or biotech environment
• Hands-on knowledge of the CQV lifecycle, clean utility systems, and aseptic filling operations
• Experience with FAT, SAT, IQ, OQ, PQ, and cleanroom protocols
• Strong technical documentation, problem-solving, and cross-functional collaboration skills