Senior Manager, Metrology Operations
Bristol Myers Squibb
3 months ago
On-site
Devens, MA
Operations
Principal Objective of the Position
- Oversee the design, execution, and maintenance of the calibration program; ensure alignment with company policy and relevant regulatory standards.
- Ensure all operations are conducted with safety as the highest priority.
Major Duties and Responsibilities
- Establish expectations to ensure compliance with EHS guidelines, cGMP regulations, company policies, and external regulations; develop/monitor procedures and action plans.
- Provide oversight to ensure operations are executed safely.
- Direct integrated preventive/on-demand calibration work order programs; manage metrology team, calibration data sheets, and job plans master data.
- Manage metrology tools; develop/maintain calibration interval management (including interval extension tasks).
- Develop/approve SOPs and technical documentation; ensure routine calibration/instrumentation per operating procedures.
- Ensure end-user training; coordinate spare parts/materials for calibrations/corrective activities.
- Ensure compliance of metrology work orders; manage metrology quality events (tracking, completion) and support investigations.
- Perform risk mitigation and troubleshooting (root cause/corrective actions), lead FMEA, and partner with RCM.
- Manage KPIs/goals, departmental budget (including SOX compliance), departmental budget for labor/materials and outside services.
- Process NOEs, NTRs, QEs, CAPAs, and audit responses by due dates.
Knowledge/Skills (required/preferred)
- Required: aptitude for engineering principles/automation; Maximo (or other CMMS); manage personnel and financial resources; ability to work in SOP/cGMP regulatory oversight.
- Preferred: familiarity with relay ladder logic/PLC/DCS; DeviceNet/Foundation Fieldbus; Rosemount A.M.S. Software.
- Experience with calibration/maintenance on biotech manufacturing instrumentation (e.g., bioreactors, chromatography skids, CIP, WFI stills, clean steam generators, autoclaves, freezers/refrigerators, incubators).
Qualifications
- BS preferred; minimum 12 years’ experience in metrology operations or engineering supporting biologic process manufacturing and/or manufacturing equipment.
- Prior managerial experience (selecting, motivating/retaining teams; managing personnel issues; planning/administering financial resources).
Compensation/Benefits (explicit)
- Devens, MA, US: $134,550–$163,039.
- Benefits include: medical/pharmacy/dental/vision; wellbeing support; 401(k) and insurance/disability.
- Paid time off (role/location-dependent).
Application Instruction
- If the role doesn’t perfectly match your resume, you are encouraged to apply anyway.
- Oversee the design, execution, and maintenance of the calibration program; ensure alignment with company policy and relevant regulatory standards.
- Ensure all operations are conducted with safety as the highest priority.
Major Duties and Responsibilities
- Establish expectations to ensure compliance with EHS guidelines, cGMP regulations, company policies, and external regulations; develop/monitor procedures and action plans.
- Provide oversight to ensure operations are executed safely.
- Direct integrated preventive/on-demand calibration work order programs; manage metrology team, calibration data sheets, and job plans master data.
- Manage metrology tools; develop/maintain calibration interval management (including interval extension tasks).
- Develop/approve SOPs and technical documentation; ensure routine calibration/instrumentation per operating procedures.
- Ensure end-user training; coordinate spare parts/materials for calibrations/corrective activities.
- Ensure compliance of metrology work orders; manage metrology quality events (tracking, completion) and support investigations.
- Perform risk mitigation and troubleshooting (root cause/corrective actions), lead FMEA, and partner with RCM.
- Manage KPIs/goals, departmental budget (including SOX compliance), departmental budget for labor/materials and outside services.
- Process NOEs, NTRs, QEs, CAPAs, and audit responses by due dates.
Knowledge/Skills (required/preferred)
- Required: aptitude for engineering principles/automation; Maximo (or other CMMS); manage personnel and financial resources; ability to work in SOP/cGMP regulatory oversight.
- Preferred: familiarity with relay ladder logic/PLC/DCS; DeviceNet/Foundation Fieldbus; Rosemount A.M.S. Software.
- Experience with calibration/maintenance on biotech manufacturing instrumentation (e.g., bioreactors, chromatography skids, CIP, WFI stills, clean steam generators, autoclaves, freezers/refrigerators, incubators).
Qualifications
- BS preferred; minimum 12 years’ experience in metrology operations or engineering supporting biologic process manufacturing and/or manufacturing equipment.
- Prior managerial experience (selecting, motivating/retaining teams; managing personnel issues; planning/administering financial resources).
Compensation/Benefits (explicit)
- Devens, MA, US: $134,550–$163,039.
- Benefits include: medical/pharmacy/dental/vision; wellbeing support; 401(k) and insurance/disability.
- Paid time off (role/location-dependent).
Application Instruction
- If the role doesn’t perfectly match your resume, you are encouraged to apply anyway.