Location
Dallas, TX, United States
Posted on
May 26, 2023
Profile
Position: Principal Commissioning/Validation Engineer I
Location: Athens, GA
Duration: 12 months
Pay Rate: $30/hr on w2 without benefits
Pay Schedule: Bi Weekly
Duties:
Duties 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:
Skills Aseptic processing Protocol generation Sterilization Validation FDA/USDA
Education:
Bachelors , preferable in a science or engineering related field
Schedule Notes:
Required Skills:
HVAC,VALIDATION ENGINEER,CGMP,FILLING LINES,BIOPHARMACEUTICAL,
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