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Metrology Supervisor

2 months ago


Devens, Massachusetts, United States Bristol-Myers Squibb Full time
Job Summary

Bristol-Myers Squibb is seeking a highly skilled Metrology Supervisor to join our Biopharm Manufacturing team. As a key member of our team, you will be responsible for ensuring compliance with regulatory guidelines, managing the day-to-day activities of the Instrumentation and Calibration group, and developing and maintaining Calibration Interval management programs.

Key Responsibilities
  • Regulatory Compliance: Supervise and ensure compliance with EHS guidelines, cGMP regulations, company policies, and other external agency regulations during work execution.
  • Instrumentation and Calibration Management: Manage the day-to-day activities of the Instrumentation and Calibration group, including technician training, deployment, work execution, work review, and approvals.
  • Metrology Team Management: Manage the Metrology team with responsibility over all Calibration Data Sheets and Metrology Job Plans Master Data within the system.
  • Metrology Tools Management: Manage the use and application of all Metrology Tools.
  • Calibration Interval Management: Develop and maintain Calibration Interval management programs, including minimally invasive instrumentation tasks that support Calibration interval extension.
  • Technical Documentation: Develop and/or approve SOPs and other technical documentation required for Metrology.
  • Instrumentation Activities: Ensure routine calibration and instrumentation activities are performed in accordance with established guidelines and operating procedures.
  • User Training: Define and ensure end-user training on Metrology Data Sheets and Work Order processing within the related business system.
  • Spare Parts Management: Work with the Spare Parts group to ensure proper materials and parts are identified and available to sustain Calibrations and Corrective activities.
  • Metrology Work Orders: Ensure the proper execution and compliance of Metrology work orders.
  • Quality Event Support: Provide support to other departments in the investigations and resolutions of Metrology-related Quality Events.
  • Risk Mitigation and Troubleshooting: Conduct basic risk mitigations options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems.
  • Instrument Diagnostics: Monitor instrument diagnostics through Emerson A.M.S. Software and plan corrective predictive maintenance around instrument needs.
  • Installation and Maintenance: Perform, as needed, a variety of installation, calibration, maintenance, etc.
Qualifications and Experience
  • Education: Knowledge of maintenance, operations, and engineering generally attained through studies resulting in a B.S. in engineering or a related discipline, or its equivalent.
  • Experience: A minimum of 5 years of experience in Maintenance or Operations of Biopharm Manufacturing and Manufacturing Equipment Support with relevant experience in metrology.
  • Travel: Occasional travel is required for seminars and projects.
  • Leadership Experience: Previous lead experience that demonstrates proficiency in selection, motivating, and retaining a superior team, effectively managing personnel issues, and planning and administering financial resources.
  • Computer Literacy: Computer literate in Maximo or similar computer-based calibration program highly desirable.
  • Instrumentation Knowledge: Familiarity with basic relay ladder logic, programmable logic controllers, and distributed control system is desired.
  • Instrumentation Experience: Experience with DeviceNet and Foundation Field bus instrumentation highly desirable.
  • Software Experience: Experience with Emerson A.M.S. Software desirable.
  • Regulatory Knowledge: Experience in working in an environment governed by SOPs and cGMPs and the know-how to work and manage within a regulatory oversight.
  • Instrumentation Experience: Experience in both calibration and maintenance of instrumentation on biotech manufacturing equipment, including bioreactors, chromatography skids, centrifuge skids, ultra-filtration skids, CIP skids, WFI stills, Clean Steam Generators, Autoclaves, Freezers, Refrigerators, Incubators, etc.