Previous Pharmaceutical/Biotech/Medical Device experience.
The Validation Engineer - Requalification position is responsible for Validation Services supporting qualification activities associated with refrigerators, incubators, walk-in freezers/incubators, warehouse, temperature mapping, autoclaves, dehydrogenation tunnels, lyophilizers, vial washer, tank SIP, filler, aseptic processing, including document generation and revision.
- Generation of protocols, summary reports, and protocol exceptions
- Scheduling and execution of qualification activities
- Qualification data collection and analysis against acceptance criteria
- Documentation updates (SOPs, Forms, etc.)
- Meeting attendance and project coordination
Experience (may vary depending on site size/scope)
- Tank SIP
- Lyophilizers SIP
- Autoclave Sterilization
- Dehydrogenation Tunnel PQ
- Temperature mapping and use of Biological Indicators
Los Angeles, California, United States
February 16, 2023