Vacancy expired!
- Formulation, consisting primarily of:
- Tanks (Buffer Hold, Formulation, Formulation Hold)
- Scales (Weigh, Cryovault)
- Peristaltic Pumps
- Environmental Chambers
- Powered Lifts
- Component Preparation and Processing, consisting primarily of:
- ATEC Component Prep and Processing Equipment
- Sterilizing Autoclave
- Parts Washer
- CIP/SIP
- Filling, consisting primarily of the following:
- Vial Washer
- Depyrogenation Tunnel
- Vial Liquid Filler and Stoppering
- Vial Capper
- Open Active RABS
- Swing Conveyor and Wall Transfer Mousehole
- SCADA and Batch Management
- Particle Counters
- Facilities/Utilities, consisting primarily of the following:
- Air Handling Units
- CIP
- Clean Utilities tie-ins (e.g., Process Air, Instrument Air, WFI), Clean Steam
- Rooms/Area Qualifications
- Working closely with the CQV Senior Lead, Equipment Vendors, and Operation personnel, perform the Validation related to Formulation, Component Preparation and Processing, Vial Filling, and Facilities.
- Execution of IQ/OQ protocols.
- Participate in discrepancy generation and closure.
- Participate in Report generation and closure.
- Assist with generation of Validation deliverables such as traceability matrices, assessments, and other supporting documentation.
- Engineering or technical degree preferred
- Minimum 2 years GxP experience in respective work stream area (Formulation/Component Prep/Processing/Filling/Facilities)
- COVID/Vaccine project experience is a plus
Vacancy expired!