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Position Summary:Provide strategic direction and oversight of the site calibration program to assure alignment with regulatory requirements in all aspects of calibration performance and out-of-tolerance event management (trending and unique event management). Position is a Subject Matter Expert role reporting to the site Maintenance and Calibration Senior Manager.
The Metrology Engineer will be expected to assess all aspects of the calibration program and drive continuous improvement throughout the processes and procedures. This position may be asked to interact directly with regulatory agencies to defend the calibration program during inspections and own any applicable related finding records and CAPA. As a SME role, this position is expected to interface with project managers and assist with new instrumentation specification to support biologics manufacturing; ensuring alignment with preferred manufacturer/model initiatives to drive standardization and maintainability.
Additional SME functions include technical assistance for any issues related to process control instrumentation and CMMS utilization to support calibration as well as change control impact assessments and investigation support as instrumentation SME. This position supports and resides at the Bristol Myers Squibb Syracuse, NY commercial biologics manufacturing site.
- Assure that required process, utilities and laboratory equipment calibrations are performed in compliance with cGMP regulations, company policies and procedures, and meet Federal and local governmental agency regulations. Interface with regulatory agencies in support of inspections; defending the calibration program and owning any findings/CAPA.
- Manage Out of Tolerance (OOT) Impact Assessment and trending processes. Perform impact assessments for calibration standards (test equipment) that are found OOT.
- Manage test equipment recertification strategy and ensure required traceability. Assists with performance of vendor audits for test equipment recertification laboratories.
- Ensure filing, data entry and electronic records of all calibrations remain in an inspection-ready state.
- Periodically report to management and functional groups departmental highlights; Metrology-related metrics.
- Perform impact assessments for quality management system change controls on GMP equipment related to instrumentation modifications/additions.
- Serve as contract administrator for external calibration services.
- Perform investigations to determine causal factors and root cause for associated instrumentation and related systems failures. Determine and implement appropriate CAPA to prevent recurrence.
- Interface with project managers and assist with new instrumentation specification to support biologics manufacturing; ensuring alignment with preferred manufacturer/model initiatives to drive standardization and maintainability.
- Create, review, and revise existing SOPs and CMMS Data Sheets for accuracy of content.
- Assist in technician troubleshooting and repair of electronic and electromechanical components and systems as SME.
- Assignments are completed without detailed instructions. The work at this level is characterized by focus on independent execution of routine duties/responsibilities.
- Possess a thorough understanding of cGMP requirements as it relates to management of a calibration program in a regulated industry.
- Possess a strong competency in process control instrumentation utilized in the biologics manufacturing or related industry.
- Computer literate in Computerized Maintenance Management Systems (CMMSs). Maximo or similar program.
- Knowledge in the principles of calibrations and basic principles of mechanical and electrical engineering.
- Ability to conduct Quality Event Investigations and apply appropriate CAPA. Possess a strong demonstrated competency in technical writing and written communication.
- Possess a thorough understanding and ability to support technician execution of a variety of calibration, maintenance, and repair duties on complex laboratory and manufacturing equipment and following SOPs in accordance with cGMPs.
- BA/BS Engineering degree or other technical field highly desirable with a minimum of 5 to 10 years relevant experience in the Metrology field or equivalent experience.
- 5 to 10 years experience in the Biotechnology and/or pharmaceutical industry, highly desirable.
- External technician certifications in the Metrology field desirable.
- This position is in a manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE). This role may require contact with hazardous materials such as caustic, acids and steam.
- This position is primarily an office-based role, however, frequent entry into manufacturing and critical utility operations work areas is expected to perform evaluations and assessments on current practices.
- This position requires up to 10% of travel.
- Periodic travel is expected for company functions, industry conferences, vendor audits, etc.
- This position may be asked to formally supervise an associate engineer, contract services provider, and/or support technician.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to ...@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.