Job Description

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

The Director, Engineering Operations directs the consolidated site functions of Engineering, Maintenance, Facilities, and Validation.  The individual in this position provides strategic leadership to ensure General Manager and corporate initiatives are properly translated, developed, and deployed at the site level to achieve exceptional best-in-class results.  To ensure a cohesive and aligned site operation, the scope of responsibilities identified for this position impacts all departments at the site including Manufacturing Operations, Engineering Operations, Strategy and Business Operations, EHS, Quality Operations and Functional Site Partners (MS&T, Procurement, Supply Chain, HR, IT, Finance, and Security).

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities

Knowledge

• Extensive knowledge of best-in-class engineering, maintenance, facilities and/or validation operations
• Extensive knowledge of pharmaceutical operations – preferably gained via experience leading aseptic manufacturing and/or aseptic manufacturing technical support teams
• Extensive understanding of cGMPs, best manufacturing practices, regulatory health authority CMC requirements, EHS regulations & compliance
• Extensive knowledge of strategic planning, balanced scorecards, budgeting, scheduling, contract management, operational excellence, continuous improvement, deviation and CAPA management, project management (including technical transfer of new and existing products), benchmarking, and training.

Skills and Abilities

Leadership

• Ability to connect and collaborate across internal and external organizations
• Ability to recruit, train, manage, and mentor a highly functioning, diverse, and effective team
• Ability to act independently and with minimal direction from GM

Critical Thinking and Problem Solving

• Ability to think creatively, critically, and strategically, and to solve problems in a complex global work environment with urgency and agility
• Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, and utilizing data and risk analysis tools
• Ability to manage competing priorities, need for results, compliance, and desire for continuous improvement

Teamwork and Collaboration

• A team player with the ability to influence others internally and externally in a matrixed organization
• Strong interpersonal and teamwork skills coupled with the ability to take risks and drive decisions that get results
• Demonstrated appreciation for and recognition of others, including peers, for exceptional performance

Professionalism and Strong Work Ethic

• Capable of successfully managing multiple projects and priorities in a responsive, professional, and customer service-oriented manner
• Willing to work irregular hours, rotating shifts, weekends, and holidays, as necessary however, strives to create an environment that provides an acceptable work/life balance
• Willing to travel as needed

Organization and Communication Skills

• Excellent verbal, written and presentation skills, command of communication and project management principles, techniques, and tools, i.e. Microsoft Project, Excel, PowerPoint, etc.
• Ability to escalate issues as appropriate, effectively plan and facilitate meetings, create action plans, and ensure completion with a well thought out path forward
• Ability to plan work schedules and set and adjust priorities

DUTIES AND RESPONSIBILITIES

Leadership

• Recruit, hire, train, manage, and mentor a diverse team of top talent to lead functional departments within areas of responsibility; and periodically update all Job Descriptions to appropriately reflect GM expectations that support a best-in-class operation
• Collaborate with peers, GM, and HR to ensure top talent and high performers have periodically updated development plans that include a variety of activities including, but not limited to, rotations, shadowing, special projects, participation in leadership programs or courses, and development opportunities to strengthen areas for improvement
• Take responsibility for personal development and ensure succession plans are in place for areas of responsibility
• Create and meet or exceed annual department goals, objectives and measurable metrics that support site and corporate vision, goals, objectives, and metrics
• Create and adhere to department budget; collaborate with peers to redistribute funds as needed so overall site budget remains within expected range; ensure alignment with Finance
• Participate in and volunteer for at and above site leadership teams, special projects, assignments, and steering committees as appropriate and always represent the site, yourself, and leadership team in a professional and positive manner
• Represent site Engineering Operations in above site interactions as required and ensure site adopts and adheres to corporate standards
• Perform additional duties, including representing site GM, as requested
• Lead areas of responsibility to carry out major duties and responsibilities as defined below:

Engineering

• Establish and maintain an overall engineering program that is best-in-class and that complies with appropriate regulations and corporate policies and guidelines
• Lead site capital budget process including P1 and P2 updates and ensure alignment between GM, Finance, site Department Heads, and global engineering
• Partner with global engineering and site Department Heads to develop, maintain and communicate a comprehensive 3-5-year capital plan to support the site strategic plan and that considers necessary facility, equipment, and utility repairs, upgrades, and replacements
• Partner with global engineering and site Department Heads to identify best-in-class equipment and technologies and provide upgrades and modifications as appropriate
• Manage capital projects to ensure site has the facilities and equipment necessary to meet strategic objectives including optimized quality, cost, safety, and service objectives
• Ensure capital projects are managed using required project management tools
• Provide guidance and support for site design, build and commissioning efforts and ensure compliance with all regulatory requirements and best practices
• Interface with local entities to obtain expedited permits and reviews as required
• Support Manufacturing, Maintenance, Laboratories, and EHS to develop and maintain labor, yield, scrap, and capacity standards
• Partner with Manufacturing, Maintenance, Laboratories, and EHS to identify and champion cost reduction, safety, and efficiency projects
• Perform other engineering related duties as required

Maintenance

• Establish and maintain an overall maintenance program that is best-in-class and that complies with appropriate regulations and corporate policies and guidelines
• Partner with Owners and Engineering to select and obtain critical utilities and GMP equipment necessary to meet strategic objectives including optimized quality, cost, safety, and service objectives
• Maintain site critical utilities and GMP equipment in a manner that meets all quality, service, safety, and cost metrics and minimizes interruption to the production schedule
• Provide setup, run, and tear down support to Manufacturing in a manner that meets all regulatory requirements and minimizes interruption to the production schedule
• Develop, implement, maintain, and continuously improve best-in-class predictive and preventative maintenance, reliability, and metrology programs and that adhere to corporate standards and regulatory requirements
• Perform other maintenance related duties as required

Facilities

• Establish and maintain an overall facilities program that is best-in-class and that complies with appropriate regulations and corporate policies and guidelines
• Partner with Owners and Engineering to design non GMP facilities, including administrative areas, and common areas such as meeting rooms, and cafeteria
• Ensure that all non GMP, administrative, and common areas comply with BMS facility standards, remain neat and orderly, repaired, and are cleaned on a periodic basis according to need (including increases in cleaning requirements during pandemic situations)
• Serve as the BMS interface with all contract service organizations that provide contingent workforce at the site
• Perform other facility related duties as required

Validation

• Establish and maintain an overall validation program that is best-in-class and that complies with appropriate regulations and corporate policies and guidelines
• Provide validation support for new and existing critical utilities, GMP equipment, facilities, processes, and computer systems
• Develop, implement, maintain, and continuously improve best-in-class validation programs and that adhere to corporate standards and regulatory requirements
• Provide technical and problem-solving support to internal and external stakeholders as required
• Participate in internal and external regulatory audits as requested
• Support technical transfer and validation of products as required
• Perform other validation duties as required

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EDUCATION AND EXPERIENCE (As Applicable)

• BS Bachelor’s Degree required - Prefer degree to be in an engineering related field
• Master’s Degree preferred
• Five (5) years of experience leading technically complex projects in an aseptic manufacturing environment preferred
• Five (5) years leadership experience required
• Clean room or aseptic manufacturing experience is preferred
• Fifteen (15) years progressive experience in one or more areas of aseptic manufacturing, aseptic manufacturing support, or strategy and business operations
• Experience with multi year CapEx projects of $200MM + (Design through Full Qualification)
• Experience with Sterile Fill projects implementing barrier isolation technology
• Knowledge of cGMP facility design standards and Regulatory requirements

WORKING CONDITIONS: (US Only)

• Work is performed either remotely or in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

PHYSICAL /MENTAL DEMANDS: (US Only)

• The incumbent will be required to type for up to 6 hours per day.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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. 

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

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.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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