Principal Commissioning/Validation Engineer I

Company: TalentBurst, Inc.
Location: Athens
Posted on: May 27, 2023

Job Description:

Job Title: Commissioning/Validation Engineer I
Location: Athens, GA 30601
Duration: 5 Months Extendable Contract
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TalentBurst offers comprehensive benefits to temporary employees at a cost, they include healthcare, dental, vision, 401k and any State or Federal mandated time off.
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Job Description:

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• 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:
  
  
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  • Aseptic processing
    
  • Protocol generation
    
  • Sterilization
    
  • Validation
    
  • FDA/USDA -
    
    Education: - - - - - - - - -
    
    
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    • Bachelors, preferable in a science or engineering related field
      

Keywords: TalentBurst, Inc., Athens , Principal Commissioning/Validation Engineer I, Engineering , Athens, Georgia