Validation engineer

6 days ago


Jersey City, New Jersey, United States Kasmo Global Full time

CQV engineer :

  • Design Documentation: URS, FRS, DS, and other engineering specifications
  • Validation Processes: IQ, OQ, PQ, Process Validation (PV), Computer Systems Validation (CSV), Master Validation Plan (MVP)
  • Quality Systems: Change Control, Non-Conformances, Requalification protocols (IQ/OQ/PQ) in compliance with GMP, FDA, and other regulatory requirements
  • Regulatory Compliance: Understanding of cGxP principles, ISO 13485, ISO 14971, and 21 CFR 820
  • CQV Leadership: Leading CQV efforts for new and existing systems, troubleshooting issues, collaborating with cross-functional teams, preparing detailed validation documentation, and ensuring regulatory compliance


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