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Manager Manufacturing Engineering

To manage and lead a team of engineers responsible for providing engineering support for manufacturing.
1. Provide Engineering support of automated manufacturing production equipment for both upstream and downstream processes. Included but not limited to bioreactors, depth filtration, centrifugation, column chromatography, and Ultrafiltration/diafiltration systems. Responsibilities include troubleshooting Clean in place (CIP), Steam in Place (SIP), and process operations for a particular process step.
2. Manage team of engineers responsible for providing support to Manufacturing, Quality, Automation, MS&T, and Validation for deviation investigation, change controls, and CAPA. Perform Supervisor functions in Trackwise and provide leadership and guidance to team. Attend weekly investigation governance meetings (Investigation and CAPA), and ensure coverage at daily huddle meetings.
3. Ensure Support of Maintenance activities, including review and approval of Preventative maintenance (PM), drawing updates, and support of out of Specification investigations related to Calibration of critical equipment. Attend Active maintenance governance meetings and drives continuous improvement for equipment robustness as it pertains to engineering team responsibility.
4. Provide support as needed for technical transfer of new or modified processes into the Large Scale Cell Culture facility. Work cross functionally with MS&T, Manufacturing, Automation and Validation on development of recipes and Delta V functionality needed to support new/modified process.
5. Provide oversight and ownership of site Functional Specifications for Syncade Recipes and Delta V phases, working closely with Automation.
6. Support and or Lead future capital projects from start to finish, including defining user requirements, supporting installation, commissioning, and Validation activities including IQ, OQ, PQ, ensuring equipment functions to current User requirement specifications. Ensure construction activities are performed to site specifications, PM programs are updated as needed, and perform design review (including Factory and Site acceptance testing as needed). Work closely with Project Engineering to understand capital expenditure requirements.
7. Provide Audit support as needed, as a technical SME of the equipment, facility, and operational phases and recipes.
8. Attend governance meetings for Validation Steering committee, Site Quality Council, and Local Change Review Board as backup for Associate Director.
? The successful candidate will have a BS in Engineering (Chemical or Mechanical preferred) with 8 years plus experience (or equivalent) with manufacturing equipment support in the Biotechnology manufacturing industry. Minimum of 4 years experience managing people highly desired.
? Proven ability to work in a cross functional environment understanding the importance of working in a compliant GMP facility.
? The individual should have the ability to manage and organize multiple complex technical projects and familiarity with the manufacturing operations of large scale production facilities as well as GMP experience.
? Significant knowledge and proven expertise of engineering principles related to and expertise with typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to bioreactors, filtration and ultra filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and glass washers.
? Candidates must be effective in both a team environment and an individual contributor role.
? Ability to work extended hours or a modified work schedule as required for coverage of 24/7 manufacturing operation. The position is Monday through Friday, first shift, but requires on-call availability
? The job requires high level of technical knowledge and process analytical capability. The candidate should have the ability to proactively troubleshoot.
? Strong project management skills/experience desired.
? Knowledge of Delta V, or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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