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Validation Engineer

4 months ago

Athens, United States Astrix Inc Full time

Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Validation Engineer to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference

Shift: M-F 1st shift

Type: 7 month contract

Pay: $45/hr

  • Validation Engineer 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
  • Validation Engineer Required Qualifications:BS in a relevant Science or Engineering
  • 3-5 years of GMP Validation experience including Computer System Validation