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- Perform Smoke studies and assist in semiannual 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/USDA
- Bachelors , preferable in a science or engineering related field
- Vision insurance
- 5 years
- 8 hour shift
- Day shift
- In-person
- Manufacturing facility
- Warehouse
Validation Engineer - Athens, United States - Incubation Systems Private Limited
Description
*Title: Validation Engineer*Location: Athens, GA* *30601
*Contract duration : 6 Months Contract
*Hours: 40 hrs/week*Duties:
Skills:
Education:
Job Type:
Contract
Pay:
$ $45.00 per hour
Benefits:
Experience level:
Schedule:
Work setting:
Work Location:
In person