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- 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.
- septic processing.
- Protocol generation.
- Sterilization.
- Validation.
- FDA/USDA.
- Bachelors , preferable in a science or engineering related field.
Validation Engineer - Athens, United States - Cynet Systems
