RCA & Compliance Engineer
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.
DUTIES AND RESONSIBILITIES:
Define, coordinate, and own the Problem Solving (RCA / FRACAS / Lessons Learned) end to end procedure, performance and governance.
Lead investigator for Site Engineering, leading quality events and critical safety investigations.
Applies Root-cause, 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.
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 AND SKILLS:
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.
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 . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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