Validation Engineer I II

Responsibilities:

• Excellent employment opportunity for a Validation Engineer I/ II in the Athens GA area. (onsite)
• Perform Smoke studies and assist in semiannual 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 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:

• Bachelors 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