Îll Therapy Facility - Compliance Engineer

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 Duties & Responsibilities Define, coordinate, and own the Problem Solving (RCA / FRACAS / Lessons Learned) end to end procedure, performance, and governance for the Cell Therapy Facility (CTF). Lead investigator for CTF Engineering: quality events and critical safety investigations. Applies Root-Cause Analysis, Root-Cause Failure Analysis (RCA, RCFA) and Failure Reporting, Analysis, and Corrective Action System (FRACAS) processes and tools when performing RCA. Own the quality of RCA outcomes through deployment of RCA Score Card, evaluating effectiveness of CAPA through Poka-Yoke, Mistake Proofing, and Engineering Solutions. Support Reliability team in developing Design FMEA / Process FMEA and other relevant LCAM requirements. Including use of FMEAs during RCA Process. Supports the development of engineering solutions to repetitive failures and all other problems that adversely affect plant operations in the areas of capacity, quality, cost, or regulatory compliance issues. Prevents compliance issues by taking proactive approach and collaborating with engineering teams related to equipment/system LCAM. Will serve as the site primary representative to the Local Change Control Review Board (LCRB), Change Action Review Board (CRB), and the Deviation Intake Huddle. Will also serve as an ad hoc member to the Investigation Review Board (IRB). Develops compliance plans by researching, analyzing, selecting, and applying compliance engineering concepts, approaches, techniques, and criteria. Mentor / Coach / Train team members on Problem Solving / Root Cause Analysis. Adhere to all plant safety policies and procedures and proactively identify unsafe conditions. Broad knowledge of Good Manufacturing Practices, Governing 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. Customer Service is paramount, therefore must 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. Periodically will assess with the customer that expected service level is being attained and must strive to exceed such expectations. Will interface with regulatory bodies and be accountable for non-conformance investigation thoroughness with appropriate and timely CAPA implementation. Ensure compliance with plant safety regulations and environmental regulatory requirements. Knowledge & Skill Degree in Science or Engineering, generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience. A minimum of 5 years of direct relevant experience in engineering and/or maintenance. Direct experience in reliability engineering, root cause analysis or asset/systems lifecycle engineering is preferred. Experience with Health Authority Inspections, External Auditors, Corporate and Internal Auditors preferred. Familiarity with distributed control systems and automation. A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required. The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management. Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams, and Standard Operating Procedures. Proven ability working in a matrix environment and leading multi-level / cross functional teams to achieve the highest performance in meeting site and departmental objectives.
LI-Ons 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 [email protected]. 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.