Validation Engineer

4 weeks ago


Athens, United States Cynet Systems Full time
Job Description:
  • 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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