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Senior Quality Engineer
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Full-time
- The Senior Quality Engineer will support our new manufacturing plant in King of Prussia, Pa focusing on continuous improvement in quality, process control, material efficiency, and start-up of a new GMP manufacturing plant.
- Provide CQV (commissioning, qualification, and validation) support for our new manufacturing facility.
- Responsible for Project Validation Master Plans (PVMP), Commissioning Test Plans (CTP), IQ/OQ/PQ protocols, Environmental Monitoring PQ protocols, summary reports.
- Manage change controls covering all actions required to complete equipment, facility/utility commissioning and qualification for new analytical or manufacturing laboratories.
- Complete qualifications of automated utilities, manufacturing and packaging equipment/ systems such as water systems (RODI, USP PW and WFI), Clean Steam, Clean compressed gases (Nitrogen and Compressed Air), Building Automation Systems (BAS), HVAC equipment, cold storage room, autoclave/sterilizer, parts/glassware washers, vessels, mixers, milling equipment.
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