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Responsibilities:

• Excellent employment opportunities for a Principal Commissioning/Validation Engineer in the Athens, GA area.
• 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 Pharmaceutical grade utilities (water HVAC, gases) Support Maintenance, Engineering and Production Departments 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
  

Experience:

• Bachelor's, preferable in a Science or Engineering related field
• Skills Aseptic processing Protocol generation Sterilization Validation FDA/USDA
• Required Skills: HVAC, VALIDATION ENGINEER, CGMP, FILLING LINES, BIOPHARMACEUTICAL