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The Associate Director GMP Maintenance provides leadership and direction to the 24/7 GMP Maintenance team supporting the Devens Site Biologics Manufacturing Operations. The primary responsibility of this role is the management of the GMP Maintenance team within the Devens Site Engineering Department. This GMP Maintenance team is responsible for ensuring that all Devens GMP manufacturing facilities, systems, and equipment are operated and maintained to ensure operational and inspection readiness. The Associate Director GMP Maintenance is responsible for developing, implementing, and maintaining a strategic plan to ensure 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. Ensure that the right support structure is in place to facilitate compliance with those requirements.

• Supports the development of related procedures and programs, implement and monitor performance. Identifies areas of opportunity and prepares specific action plans to increase awareness and to maintain compliance.

• Set short- and long-term strategies for the team that aligns with Site Engineering and Devens Biologics objectives. Communicate a clear vision for the team aligned with the Devens Site and overall business 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.

• Broad knowledge of Good Manufacturing Practices, Building Codes, OSHA regulations, and Industry Regulations related to the manufacture of pharmaceutical products.

• Develops relationships with diverse groups across the client base at the Devens site. Work within a team environment with other Site Engineering functions, including Engineering and Plant Engineering in a matrix organization.

• Ability to build and sustain strong relationships with internal and external stakeholders including Manufacturing, Quality, EHS, and local community and regulatory agencies to meet site and business requirements.

• Develops and monitors key performance indicators for maintenance operations. Drives appropriate actions to mitigate performance issues.

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.

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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments 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 cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1581906

Updated: 2024-06-25 04:21:39.924 UTC

Location: Devens-MA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.