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Process Engineer
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- Responsibilities: Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence, Lead CAPA investigations and at times manage the implementation of CAPA. Own manufacturing related change controls.
- Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
- Review production documentation and perform quality walk-throughs during manufacturing events.
- Participate in continuous improvement teams such as s, Gemba and the Production Systems (GPS).
- Stay current with biopharmaceutical industry best practices and technologies.
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