What are the responsibilities and job description for the CQV Engineer position at Katalyst Healthcares and Lifesciences?
Job Details
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.
- 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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