Validation Engineer

4 weeks ago

Athens, United States SPECTRAFORCE Full time

Job Title: Validation Engineer I/ II

Duration: 07 Months

Location: Athens, GA 30601

Pay Range: $45- $48/hr on W2

Roles and responsibilities:

  • 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:

  • Aseptic processing
  • Protocol generation
  • Sterilization
  • Validation
  • FDA/USDA


Education:

Bachelors , preferable in a science or engineering related field.

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