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Compliance / Deviation Investigator
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Full-time
- ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries.
- Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
- ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
- Performance of Fact Finding, Assessment and Determination of Root Cause (RCA), generation of CAPAs, and coordination and management of cross-functional teams.
- A high level of aptitude for cGMP biopharmaceutical manufacturing processes (upstream/downstream), including process knowledge of UF/DF Systems, Chromatography, Bioreactors, Seed Train, Disposable Technologies (SUMs, SUBs), Clean-in-Place (CIP), and Steam-in-Place (SIP).
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