Job Description
Facility & Operations Manager – GMP Clean room
The Facility & Operations manager is responsible for monitoring, managing, and ensuring compliant operation of GMP cleanroom facilities used for cell therapy and viral vector manufacturing. The role focuses on cleanroom garment management, biohazard waste handling, environmental condition monitoring, cleaning and disinfection (including fogging), and associated GMP documentation, ensuring continuous compliance with regulatory and biosafety requirements.
Key Responsibilities
1. Cleanroom Garment Management
- Manage issuance, collection, storage, and inventory of cleanroom garments (sterile and non-sterile) for classified areas.
- Ensure appropriate gowning practices are followed for different cleanroom grades (e.g., Grade A/B/C/D).
- Coordinate with approved vendors for garment laundering, sterilization, integrity checks, and qualification.
- Maintain garment usage logs, traceability records, and reconciliation.
- Su...
The Facility & Operations manager is responsible for monitoring, managing, and ensuring compliant operation of GMP cleanroom facilities used for cell therapy and viral vector manufacturing. The role focuses on cleanroom garment management, biohazard waste handling, environmental condition monitoring, cleaning and disinfection (including fogging), and associated GMP documentation, ensuring continuous compliance with regulatory and biosafety requirements.
Key Responsibilities
1. Cleanroom Garment Management
- Manage issuance, collection, storage, and inventory of cleanroom garments (sterile and non-sterile) for classified areas.
- Ensure appropriate gowning practices are followed for different cleanroom grades (e.g., Grade A/B/C/D).
- Coordinate with approved vendors for garment laundering, sterilization, integrity checks, and qualification.
- Maintain garment usage logs, traceability records, and reconciliation.
- Su...
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