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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.
- Write and execute protocols and complete final reports.
- 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.
- Develop and assist 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.
- Bachelors , preferable in a science or engineering related field, and 2+ years of relevant experience.
- Understanding of cleaning validation concepts and principles.
- Understanding of pharma grade utilities preferred (water, HVAC, gases).
Validation Engineer - Athens, United States - The Fountain Group
Description
Job Description
Job DescriptionJob Duties:
Qualifications:
Browse our website below for additional information on our company.
The Fountain Group
4505 Woodland Corporate Blvd, Tampa, FL 33614
"We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people."
Company Description
The Fountain Group is a nationwide staffing firm with over 80 Fortune clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r\r
Browse our website below for additional information on our company.\r
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The Fountain Group\r
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4505 Woodland Corporate Blvd, Tampa, FL 33614\r
"We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people."