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Company | Bristol Myers Squibb |
Address | Devens, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-06-21 |
Posted at | 11 months ago |
Working with Us
- Leads technology transfer efforts for new processes and product implementation
- Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
- Facilitate deviation prevention and deviation closure through site quality systems
- Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating on impact assessments
- Owner of change controls for process and procedure changes
- Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.
- Functions as a technology and process subject matter expert
- Represent MSAT and interface with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
- Analyze and summarize manufacturing data to support impact assessments and investigations
- Train and support GMP operators on new procedures, processes, and changes
- Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas.
- Applies continuous improvement tools to identify and close procedural and compliance gaps
- CAPA owner for Manufacturing improvements
- Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing
- Minimum 3 years relevant experience in GMP biologic manufacturing technical or process support.
- Minimum 5 years of industry experience. Cell Therapy manufacturing experience preferred.
- BSc and/or MSc degree in Science or Chem/Bio Engineering
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