Principal Commissioning/Validation Engineer

37543918 Principal Commissioning/Validation Engineer, Athens, GA 12 months

Sigma Systems is currently looking for a Principal Commissioning/Validation Engineer

Responsibilities:

• 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 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

Requirements:

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