Sr. Manager, Maintenance, Instrument Calibrations / Metrology

Bristol-Myers Squibb Company

New Brunswick, NJ


Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us

This position will provide leadership, technical expertise and staff oversight in the management of New Brunswick Clinical Supply Operations Facilities Maintenance functions, with a focus on the CSO Instrument Calibrations program. The role will encompass the day-to-day management of instrument calibration activities, (scheduling, oversight, Maximo utilization, investigation support, metrics and reporting). In addition, the position will also support CSO departmental strategy and practice in ensuring compliance (GMP and PSM) with company policies and appropriate regulatory standards within the New Brunswick, NJ Clinical Manufacturing Facilities.

Responsibilities:

  • Serves as the technical lead and Subject Matter Expert (SME) for NBR R&D Manufacturing related production instrumentation.
  • Responsible for the planning, preparation, and timely execution of all Metrology/Calibration work activities, i.e.: monthly maintenance activities, demand activities, support of shutdown periods, corrective maintenance, preventative maintenance, predictive maintenance, etc.
  • Assists with issuance of internal permits, communications and notices as applicable to role and responsibilities.
  • Responsible for understanding, prioritizing, approving and ensuring access is granted for all work in scope calibration support vendors. As required, interfaces and coordinates with CSO F&E team, Functional Area management and IFM Calibration support.
  • Manages Metrology team staff performance and development plans. Provides compliance oversight for calibration staff.
  • Develops and reviews Calibration Data Sheets and Metrology Job Plans Master Data within the CMMS system.
  • Manages the use and application of all Metrology Tools & Standards.
  • Assists with the assessment and optimization of calibration frequencies through calibration interval management program, including minimally invasive instrumentation tasks which support Calibration interval extension.
  • Assists with developing, revising and/or approving SOPs and other technical documentation required for Metrology and Maintenance related activities.
  • Ensures routine calibration and instrumentation activities are performed in accordance with established guidelines and operating procedures.
  • Defines and ensures end user training for instrument technicians on calibration practices & techniques, Metrology Data Sheets and Work Order processing within the related business systems to ensure consistency & completeness.
  • Interfaces with the Storeroom to ensure proper materials and parts are identified and available to sustain calibrations and corrective activities.
  • Ensures the proper execution and compliance of metrology/calibration work orders and following CMMS system rules.
  • Assists in the creation, tracking and completion of metrology related Quality Events, CAPAs, and Out of Tolerance (OOT) situations. Supports Facility audits and observation responses.
  • Conducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems.
  • Assist with the safety investigations/Near Miss program and Corrective Measure implementation relevant to calibrations across the NBR R&D Manufacturing facilities.
  • Adhere to energy control procedures and lock-out/tag-out programs across the NBR R&D Manufacturing facilities.
  • Management of the change controls across the NBR R&D Manufacturing facilities. Serve as an impact assessor, reviewer and approver of change controls as applicable.
  • Partner with stakeholders and be responsible for defining user requirements for new instruments.
  • Responsible for working with groups within the NBR R&D Manufacturing space to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipment.

Qualifications:

  • Knowledge of metrology, calibrations, instrumentation, automation and electrical practices generally attained through hands-on experience.
  • Relevant BS Degree preferred.
  • Thorough understanding of metrology principles and practices including calibration methods and tolerances.
  • Minimum 10 years of experience in pharmaceutical operations and drug product intermediates along with manufacturing, packaging & labeling, and distribution of drug product in a commercial manufacturing plant or pilot plant setting.
  • Prior staff management experience a plus.
  • Knowledge of process control and instrumentation in a regulated (cGMP & PSM) pharmaceutical facility.
  • Ability to prioritize and coordinate activities within and between work groups. Able to discern priority differences and resolve issues effectively.
  • Ability to effectively interact with individuals at all levels and groups from various departments.
  • Expert knowledge of SOPs and cGMPs, and the know how to work and manage within a regulatory environment.
  • Working knowledge of company procedures and policies.
  • Adaptable to a fast paced, complex and dynamic business environment
  • Strong written, verbal and presentation communication skills; demonstrated proficiency in technical writing.
  • Knowledge of Maximo (CMMS), Emerson Delta V, Emerson AMS, PI, Infinty QMS, VeevaVault, PDHQ (Procedural Documents Headquarters), Microsoft Suite, EIMS (Electronic Incident Management System)

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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