Director, Process & Facilities Engineering (Biologics)

Director, Process & Facilities Engineering (Biologics)

28 Feb 2024
New Jersey, Newbrunswick, 08901 Newbrunswick USA

Director, Process & Facilities Engineering (Biologics)

Working with UsChallenging. 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 .Business Unit OverviewOur Global Engineering and Facilities team is responsible for the safe, sustainable, and cost-effective construction, operation and maintenance of world-class facilities that enable the discovery, development and delivery of innovative medicines that help patients prevail over serious diseases. Global Engineering partners with stakeholders to develop strategic, innovative, and robust technical solutions that are compliant and reliable for project delivery and facilities assets throughout the BMS network with a focus on safety, speed and flexibility while placing patients at the center of everything we do. Our core focus areas are Strategic Capital Planning, Project Realization, Controls, and Governance, Engineering & Technical Solutions, and Reliable Asset Solutions. Here, you’ll pursue innovative ideas, and advance professionally alongside some of the brightest minds in the industry.Position SummaryAs a Global Subject Matter Expert in Process & Facilities Engineering for Biologics and Antibody Drug Conjugates, this position will be responsible for utilizing technical expertise to identify and implement innovative solutions, lead strategic assessments lead global quality programs, and manage design activities (impacting $400MM annually) across the Global BMS Portfolio of Internal & External Operations spanning 3 continents.This role will lead the Global Program for Biologics Process Facility & Systems standards and practices throughout the BMS Network collaborating with Engineering, Operations, MS&T, Quality, and Safety teams (Site/Global) to identify, develop, and implement engineering solutions aligned to design standards and best practices. This role will influence Site and Network Master Planning and collaborate with Process Development (PD), Manufacturing Science & Technology (MS&T), and Operations organizations to implement network solutions (including standardized technologies and advanced capabilities emerging from industry) to drive innovative capital and operational solutions. This position will develop engineering solutions from feasibility through concept design solutions in partnership with Engineering, Architecture, internal stakeholders, and external vendors and will support the project lifecycle during detailed design, implementation, and commissioning/qualification.Key Responsibilities

Lead, facilitate and translate project user requirements and process operational requirements into feasibility and detailed design support documents such as: System Requirements (SRs), Operational Philosophies, Process Flow Diagrams, Process Simulation Models and Process Utility Diagrams to achieve facility integration

Interface with and respond to industry experts in regulatory including health authority representatives, environmental, GMP and OSHA regulations in a Global Environment

Partner with Process Architects to develop Manufacturing Layouts, Production Adjacencies, Material and Equipment Flows

Lead/Participate Project Peer Reviews, GMP Reviews, Process Hazard Analysis (PHA), Process Safety Management (PSM)

Provide leadership, coaching, and training for Community of Practices (COP) including both the technical processes and the behaviors necessary to optimize process execution

Utilize process simulation tools and capabilities to analyze project user requirements and design to achieve optimum design and operational outcomes

Coordinate with network and project stakeholders to develop robust design solutions that meet Safety, Quality, and Regulatory expectations

Coordinate across sites and network to implement best practices, industry trends, and internal learnings and improvements.

Collaborate with project teams to deliver technical solutions aligned to Stage Gate project deliverables and to BMS Facility and Systems Design Standards

Author and maintain facility design quality documents and engineering design standards

Identify and introduce new and enabling technologies applicable to improve process or facility designs across the company network

Achieve a cost-effective, functional outcome with the use of design guidelines and standards, value engineering, life cycle costing and engineering best practices across the company network

Maintain global expertise through ongoing training and participation in industry forums

25-50% travel as needed to ensure processes are globally designed and effectively deployed

Qualifications & Experience

Bachelor’s degree in engineering, pharmacy, or other healthcare-related field, with 15+ years of experience related to pharmaceutical/life sciences facility design and manufacturing operations, and 10+ years of experience related to BDS and/or ADC Processes and Facility Designs; an equivalent combination of education and experience may be considered

Mastery of relevant Quality compliance processes and regulations, e.g., Good Manufacturing Practices (GMP)

Thorough understanding of company policies and regulatory requirements and ability to provide subject matter expertise in relation to the management and documentation of product quality

Familiarity with discrete modeling applications (preference is FlexSim Simulation Software)

Familiarity with electronic quality system tools (Preference is Veeva Vault Software)

Strong program and project management experience with proven track-record of effectively managing cross-functional programs and multiple simultaneous projects

Demonstrated success in a people management role

Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams

Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats

Demonstrated strategic thinking capabilities with strong project management focus and ability to effectively execute on strategy while balance conflicting priorities

Demonstrated strong influential leadership capability with ability to make and act on decisions while balancing speed, quality, and risk to deliver value added business results that meet high quality requirements with tight deadlines

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 CareersWith 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 ProtocolPhysical 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.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/ (https://careers.bms.com/eeo-accessibility) 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 SquibbReq Number: R1578838Updated: 2024-02-29 03:35:33.556 UTCLocation: New Brunswick,New JerseyBristol 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.

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