Associate Director, GMP Maintenance Operations

4 hours ago

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

Bristol Myers Squibb is seeking an experienced Associate Director, GMP Maintenance to lead the 24/7 GMP Maintenance team supporting the Devens Site Biologics Manufacturing Operations. The successful candidate will provide leadership and direction to the team, ensuring the maximum efficiency and availability of manufacturing equipment, associated critical utilities, and related facilities at optimal cost and within the required expectations of quality, safety, and protection of the environment.

Key Responsibilities
  • Member of the Site Engineering Safety Committee.
  • Champions safety and compliance as a leader within the Site Engineering Department.
  • Set expectations and ensure adherence to Safety and Environmental regulations, Good Manufacturing Practices, Governing Building Codes, and other applicable industry regulations related to the manufacture of pharmaceutical products.
  • Supports the development of related procedures and programs, implement and monitor performance.
  • Set short- and long-term strategies for the team that aligns with Site Engineering and Devens Biologics objectives.
  • Develop and manage the teams through hiring, talent development, coaching, and performance management in a manner that creates an inclusive and supportive work environment.
  • Develop and implement systems and processes that minimize inconsistencies or defects in equipment that could lead to variability in equipment/system output.
  • Develop, implement, and track best in class maintenance and reliability KPI's and ensure the appropriate review process is in place so actions are being taken to address performance issues.
  • In collaboration with the Systems Lifecycle Engineering organization, define and implement strategies to ensure that equipment is operating reliably and per design specifications.
  • Identify opportunities to implement and utilize predictive analytics (including machine learning where applicable) to improve equipment uptime and availability.
  • Implement and maintain inspection readiness programs to ensure that the manufacturing equipment, systems, and facilities are always inspection-ready and maintained to the highest standards.
  • Maintain a collaborative and positive working relationship with our Integrated Facilities Management service provider to deliver best in class facilities support services.
  • Champion Safety by partnering with site and corporate EHS to develop and implement processes, procedures, and strategies to ensure that we are creating an environment and culture to keep our employees safe.
  • Utilize state-of-the-art data acquisition and analytical technology to drive asset performance while maintaining highly compliant facilities.
Qualifications & Experience
  • Bachelor's degree in a technical field, preferably Engineering.
  • Minimum 10 years pharmaceutical industry experience with specific expertise in Metrology and/or Maintenance systems, activities, and operations.
  • Minimum of 10 years' experience leading an Engineering and/or Facilities Team responsible for the critical utilities systems supporting pharmaceutical or biotech manufacturing operations.
  • Experience managing the operations and maintenance of critical utilities supporting a large manufacturing campus.
  • Experience with Quality Management Systems, specifically Change Control.
  • Experience interacting with regulatory agencies and local government official.
  • Mastery of a technical function such as metrology or automation as well as pharmaceutical processes such as building systems or manufacturing operations.
  • Specific knowledge of equipment reliability principles and processes related to maintenance best practices.
  • Knowledge and experience in supporting upstream cell culture and downstream purification processes.
  • Knowledge and experience in the maintenance and operation of clean utilities such as water for injection, pure steam, clean room HVAC systems, and Building Management Systems within a GMP manufacturing facility.
  • Working knowledge and experience with regulatory inspections preferably as an SME lead.
  • Fundamental understanding of the maintenance principles and requirements for electrical, HVAC, process heating and cooling utilities.
  • Experience leading a large team of multi-skilled trades within a regulated manufacturing environment.
  • Experience managing OPEX and/or CAPEX budgets > 10M.
  • Ability to manage or be an active team member of cross-functional project teams.
  • Must have a BA degree in Facilities Management, Engineering, OR equivalent experience.
  • Knowledge of BMS business objectives, strategies, and the pharmaceutical industry.
  • Understanding of regulatory, environmental, GMP, GLP and OSHA regulations.
  • Must have excellent leadership, communication, and presentation skills.

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