Senior Manager, Metrology Operations
Bristol Myers Squibb
4 hours ago
On-site
Devens, MA
Operations
Principal Objective of the Position
- Oversee the design, execution, and maintenance of the calibration program and 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/objectives to ensure compliance with EHS guidelines, cGMP regulations, company policies, and external agency regulations; support development of related procedures/programs, implement and monitor performance; identify opportunities and prepare action plans to maintain compliance.
- Provide oversight of all operations to be executed safely.
- Direct the use of Integrated Systems including Preventive and On-Demand Calibration Work Order Programs.
- Manage the Metrology team and oversee Calibration Data Sheets and Metrology Job Plans Master Data.
- Manage the use and application of all Metrology Tools.
- Develop and maintain Calibration Interval management program, including minimally invasive instrumentation tasks to support calibration interval extension.
- Develop and/or approve SOPs and other technical documentation required for Metrology.
- Ensure routine calibration and instrumentation activities are performed per established operating procedures.
- Define and ensure end-user training on Metrology Data Sheets and work order processing within the business system.
- Coordinate with the Spare Parts group to ensure proper materials/parts are available to sustain calibrations and corrective activities.
- Ensure proper execution and compliance of Metrology work orders.
- Manage creation, tracking, and completion of Metrology-related Quality Events.
- Support other departments in investigations and resolutions of Metrology-related Quality Events.
- Perform risk mitigation and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems; align materials, parts, tools, and skill sets to accomplish work and prioritize resources to achieve business results.
- Develop and maintain the departmental training program; ensure field personnel and direct reports maintain current training.
- Allocate resources and establish/manage/monitor/control Metrology Services work processes.
- Identify, implement, and monitor KPIs and set goals to achieve World-Class Metrology performance.
- Participate in and lead Failure Mode and Effects Analysis (FMEA) exercises with System Owners, Metrology Technicians, and Manufacturing Operators.
- Work with Reliability Centered Maintenance (RCM) programs to improve performance/reliability; use maintenance/metrology data to identify optimization opportunities, assess regulatory/policy impacts, and develop/execute action plans.
- Manage departmental budget; allocate expenses aligned to site strategy and business unit priorities while assuring SOX compliance and guarding against budget overruns (supplies, tool inventory, overtime, contracts).
- Develop departmental budget using metrics to establish labor, materials, and required outside service contracts.
- Process NOEs, NTRs, QEs, CAPAs, and audit responses by established due dates.
Knowledge and Skills (Required/Preferred)
- Demonstrated aptitude for engineering principles and building/manufacturing automation systems.
- Knowledge of Maximo or other CMMS applications (required).
- Managing personnel issues and planning/administering financial resources.
- Computer literacy in Maximo or similar calibration software (highly desirable).
- Familiarity with relay ladder logic, PLCs, and distributed control systems (desired).
- Experience with DeviceNet and Foundation Fieldbus instrumentation (highly desirable).
- Experience with Rosemount A.M.S. software (desirable).
- Experience with calibration and maintenance of biotech manufacturing instrumentation (bioreactors, chromatography skids, centrifuge skids, ultrafiltration skids, CIP skids, WFI stills, clean steam generators, autoclaves, freezers, refrigerators, incubators, etc.).
- Experience working in SOP- and cGMP-governed environments with regulatory oversight.
- Adaptable to a fast-paced, complex, ever-changing environment.
Qualifications
- BS preferred; minimum 12 years of experience in metrology operations or engineering supporting biologic process manufacturing and/or manufacturing equipment.
- Prior managerial experience demonstrating proficiency in selecting, motivating, and retaining a high-performing team; managing personnel issues; and planning/administering financial resources.
Benefits (as explicitly listed)
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support programs (BMS Well-Being Account, BMS Living Life Better, EAP).
- Financial wellbeing and protection (401(k), short/long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support).
- Paid time off: US exempt employees (unlimited PTO with manager approval) and 11 paid national holidays; Phoenix, AZ/Puerto Rico/Rayzebio exempt/non-exempt/hourly employees: 160 hours annual paid vacation with manager approval, 11 national holidays, and 3 optional holidays.
Application Instructions
- If the role interests you but your resume doesn’t fully match, apply anyway.
- Oversee the design, execution, and maintenance of the calibration program and 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/objectives to ensure compliance with EHS guidelines, cGMP regulations, company policies, and external agency regulations; support development of related procedures/programs, implement and monitor performance; identify opportunities and prepare action plans to maintain compliance.
- Provide oversight of all operations to be executed safely.
- Direct the use of Integrated Systems including Preventive and On-Demand Calibration Work Order Programs.
- Manage the Metrology team and oversee Calibration Data Sheets and Metrology Job Plans Master Data.
- Manage the use and application of all Metrology Tools.
- Develop and maintain Calibration Interval management program, including minimally invasive instrumentation tasks to support calibration interval extension.
- Develop and/or approve SOPs and other technical documentation required for Metrology.
- Ensure routine calibration and instrumentation activities are performed per established operating procedures.
- Define and ensure end-user training on Metrology Data Sheets and work order processing within the business system.
- Coordinate with the Spare Parts group to ensure proper materials/parts are available to sustain calibrations and corrective activities.
- Ensure proper execution and compliance of Metrology work orders.
- Manage creation, tracking, and completion of Metrology-related Quality Events.
- Support other departments in investigations and resolutions of Metrology-related Quality Events.
- Perform risk mitigation and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems; align materials, parts, tools, and skill sets to accomplish work and prioritize resources to achieve business results.
- Develop and maintain the departmental training program; ensure field personnel and direct reports maintain current training.
- Allocate resources and establish/manage/monitor/control Metrology Services work processes.
- Identify, implement, and monitor KPIs and set goals to achieve World-Class Metrology performance.
- Participate in and lead Failure Mode and Effects Analysis (FMEA) exercises with System Owners, Metrology Technicians, and Manufacturing Operators.
- Work with Reliability Centered Maintenance (RCM) programs to improve performance/reliability; use maintenance/metrology data to identify optimization opportunities, assess regulatory/policy impacts, and develop/execute action plans.
- Manage departmental budget; allocate expenses aligned to site strategy and business unit priorities while assuring SOX compliance and guarding against budget overruns (supplies, tool inventory, overtime, contracts).
- Develop departmental budget using metrics to establish labor, materials, and required outside service contracts.
- Process NOEs, NTRs, QEs, CAPAs, and audit responses by established due dates.
Knowledge and Skills (Required/Preferred)
- Demonstrated aptitude for engineering principles and building/manufacturing automation systems.
- Knowledge of Maximo or other CMMS applications (required).
- Managing personnel issues and planning/administering financial resources.
- Computer literacy in Maximo or similar calibration software (highly desirable).
- Familiarity with relay ladder logic, PLCs, and distributed control systems (desired).
- Experience with DeviceNet and Foundation Fieldbus instrumentation (highly desirable).
- Experience with Rosemount A.M.S. software (desirable).
- Experience with calibration and maintenance of biotech manufacturing instrumentation (bioreactors, chromatography skids, centrifuge skids, ultrafiltration skids, CIP skids, WFI stills, clean steam generators, autoclaves, freezers, refrigerators, incubators, etc.).
- Experience working in SOP- and cGMP-governed environments with regulatory oversight.
- Adaptable to a fast-paced, complex, ever-changing environment.
Qualifications
- BS preferred; minimum 12 years of experience in metrology operations or engineering supporting biologic process manufacturing and/or manufacturing equipment.
- Prior managerial experience demonstrating proficiency in selecting, motivating, and retaining a high-performing team; managing personnel issues; and planning/administering financial resources.
Benefits (as explicitly listed)
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support programs (BMS Well-Being Account, BMS Living Life Better, EAP).
- Financial wellbeing and protection (401(k), short/long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support).
- Paid time off: US exempt employees (unlimited PTO with manager approval) and 11 paid national holidays; Phoenix, AZ/Puerto Rico/Rayzebio exempt/non-exempt/hourly employees: 160 hours annual paid vacation with manager approval, 11 national holidays, and 3 optional holidays.
Application Instructions
- If the role interests you but your resume doesn’t fully match, apply anyway.