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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
- Aseptic processing
- Protocol generation
- Sterilization
- Validation
- FDA/USD
- HVAC
- VALIDATION ENGINEER
- CGMP
- FILLING LINES
- BIOPHARMACEUTICAL
- Health insurance
- Health savings account
- Dental insurance
- Vision insurance
- Flexible spending accounts
- Life insurance
- Retirement plan
Validation Engineer - Athens, United States - inSync Staffing
Description
Pay rate: $48.21/hr
Hours: 8-5pm
Location: Athens, GA- On-site
Duration: 7 months
Summary of Duties:
Bachelors , preferable in a science or engineering related
Benefits (employee contribution):