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Equipment Commissioning Specialist
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- Intermediate knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinicalmanufacturing.
- REQUIRED: Intermediate knowledge of commissioning and qualification of clean manufacturing facilities,material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems.
- PREFERRED: Commissioning and qualification of liquid nitrogen supply systems, DI Water, autoclaves, isolators,filling and capping equipment, and airflow visualization studies.
- Administer change control activities and corrective and preventive actions.b. Review, approve, and execute test protocols, validation deliverables, and plans as needed.c. Author, review, and approve SOPs, work practices, and other procedural documents.d. Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.e. Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.
- Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other client standards and regulations.b. Acts as equipment commissioning and qualification SME in internal and regulatory audits.
Expired 13 days agoInactive Job
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