Job title: CQV Engineer
Company: Katalyst Healthcares & Life Sciences
Job description: Responsibilities:
- Develop commissioning and qualification protocols for HVAC, purified water systems, clean utilities, and other critical utilities according to regulatory requirements (GMP, FDA, etc.).
- Execute commissioning and qualification activities for utilities systems, ensuring adherence to project schedules and quality standards.
- Conduct risk assessments, impact assessments, and gap analyses related to utilities systems.
- Coordinate with cross-functional teams including engineering, quality assurance, operations, and validation to ensure successful project outcomes.
Requirements:
- Generate and review commissioning and qualification documentation (IQ/OQ/PQ protocols, reports, SOPs, etc.) in compliance with regulatory guidelines.
- Participate in FAT/SAT (Factory Acceptance Testing/Site Acceptance Testing) activities for utilities equipment and systems.
- Troubleshoot utilities systems and equipment issues during commissioning and qualification phases.
- Support validation activities, including process validation and cleaning validation, as needed.
Expected salary:
Location: Brooklyn, NY
Job date: Sun, 26 Jan 2025 02:43:22 GMT
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