- 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.
- Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
- 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 5s, Gemba and the *** Production Systems (GPS).
- Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.
- Lead team meetings and facilitate multidepartment discussions.
- Stay current with biopharmaceutical industry best practices and technologies.
- Other duties as assigned.
- Bachelor's degree or equivalent experience.
- 3+ years of related experience.
- Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT).
- Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).
- Good computer skills, knowledge of Microsoft office products - Word, Excel, Office.
- Collaborate with cross-functional teams to integrate compliance measures into various aspects within manufacturing operations.
- bility to meet schedule is required; this position may infrequently include shift, weekend, or holiday work and overtime as dictated by a 365-day production schedule.
- bility to work in a cleanroom environment and comply with hygiene standards and use of clean room gowning.
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Takeda Pharmaceutical Cambridge, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
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Process Engineer - Cambridge, United States - Katalyst Healthcares and Life Sciences
