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.
The Sr. Process Engineer provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process. The Sr. Process Engineer works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions.Other responsibilities includes participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site. The Sr. Process engineer works to identify and drive continuous improvements to the manufacturing process. This position leads a small team that support 24/7 cell therapy operations.DUTIES AND RESPONSIBILITIES:
- Functions as a technology and process subject matter expert
- Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing
- Facilitate deviation prevention and deviation closure through site quality systems
- Analyze and summarize manufacturing data to support impact assessments and investigations
- Owner of change controls for process and procedure changes
- CAPA owner for Manufacturing improvements
- Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
- Leads technology transfer efforts for new processes and product implementation
- Train and support GMP operators on new procedures, processes and changes
- Applies continuous improvement tools to identify and close procedural and compliance gaps
- Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.
- Represent MSAT and interface with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
- Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements and participating on impact assessments
- Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas.
- Support to establish and track performance metrics for the team.
- Provide leadership and guidance to manufacturing support team as needed.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:Education:
- Create an environment of teamwork, open communication, and a sense of urgency
- Support the change agent in promoting flexibility, creativity, and accountability
- Support organizational strategic goals and objectives that are linked to the overall company strategy
- Drive strong collaboration within the plant and across the network
- Build trust and effective relationships with peers and stakeholders
- Deliver business results through timely and quality decision making and advice
- Foster a culture of compliance and strong environmental, health, and safety performance
- BSc and/or MSc degree in Science or Chem/Bio Engineering
- Minimum 8 years of industry experience. Cell Therapy manufacturing experience preferred.
- Minimum 6 years relevant experience in GMP biologic manufacturing technical or processsupport.
- 1+ years managing direct report
- Experience with Operational Excellence and Lean Manufacturing
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 email@example.com
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