Validation Engineer

cGxPServe
Albany, NY
Responsibilities:
  • Execute validation activities across the full equipment lifecycle (FAT, SAT, Commissioning, DQ, IQ, OQ, PQ).
  • Apply GAMP 5 methodology in a GMP-regulated environment.
  • Support Greenfield project initiatives and equipment startup.
  • Handle deviations, change controls, and validation deliverables.
  • Collaborate with cross-functional teams including QA, Engineering, and Manufacturing.
Requirements:
  • Prior experience with fill-finish equipment including syringe assembly, serialization lines, and cartoners.
  • Strong understanding of GAMP 5 and validation lifecycle documentation.
  • Hands-on exposure to Greenfield projects.
  • Excellent communication and documentation skills.
  • Experience managing deviations, CAPAs, and change controls.
Posted 2025-07-29

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