CQV Engineer

2 weeks ago


Boston, MA, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Generate, execute, review, finalize, and approve validation/qualification protocols and reports.
  • Manage and update project validation plans for specific projects.
  • ssist and deliver amendments to the qualification(s) to ensure qualification compliance within agreed upon timelines.
  • Utilize computerized asset management system for managing validation/qualification schedules.
  • Generate operational and maintenance SOPs, FATs, URSs, FRSs, validation protocols and reports.
Requirements:
  • Bachelor's degree required; B.S. in engineering preferred.
  • Experience in an Engineering or a closely related role in a manufacturing or R&D environment.
  • Experience in a GMP environment required. Experience in the pharmaceutical/API/chemical manufacturing industry preferred.
  • Experience in a Validation Engineering role generating and executing.
  • Commissioning, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols.


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