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CQV Engineer

  1. North America, East Coast
Massachusetts
  1. Contract
Competitive
  1. CAPEX Projects
38815
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CQV Engineer – Massachusetts – Pharmaceuticals – Contract

Our client is a leading American multinational CDMO specializing in the development and manufacturing of complex, highly regulated active pharmaceutical ingredients (APIs). Our client is seeking an experienced CQV/Validation Engineer to contribute to an exciting project in the New England area.

What you’ll do:
  • Generate, execute, review, finalize, and approve validation/qualification protocols and reports
  • Manage and update project validation plans for specific projects
  • Assist 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
What you’ll need:
  • 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
If you are interested, please apply now for immediate consideration and further information.

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