Principal Commissioning/Validation Engineer I
Aequor
Duties: Work Location or Remote On-site Remote? No Full time or part time? Full time Shift Hours 40/week Number of Positions 2 Any possibility of the assignment to be converted to a full-time role? Not at this time Duties
Skills
- Perform Smoke studies and assist in semi annual Media fill qualifications as a SME
- Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and warehouse areas.
- Has worked with Ellabs data loggers and software
- Write and execute protocols and complete final reports.
- Understanding of cleaning validation concepts and principles.
- Understands pharma grade utilities ( water HVAC, gases)
- Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.
- Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment.
- Develops and Assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are \"inspection ready\" at all times.
- Support Change Control, Deviation and CAPA activities
Skills
- Aseptic processing
- Protocol generation
- Sterilization
- Validation
- FDA/USDA
Vacancy posted 9 hours ago
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