Senior Specialist, Process Engineer II Job at Bristol Myers Squibb

Bristol Myers Squibb Summit, NJ 07901

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

This role is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Potential areas of responsibility include (a) providing day-to-day manufacturing support, (b) leading manufacturing investigations pertaining to the process control strategy and associated elements, (c) managing multidisciplinary projects aimed at improving the process, and (d) developing input into process automation systems to deliver advances in manufacturing strategy. These areas include creation/revision of engineering documentation and management of external resources (e.g. engineers and/or scientists) required to support the production of personalized cell therapy products. Cross-functional collaboration with SMEs from the Development Group, Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR-T manufacturing organization.

Responsibilities include, but are not limited to, the following:

  • Provide on the floor process support for ongoing manufacturing activities when needed.
  • Lead deviation investigations utilizing root cause analysis tools.
  • Develop inputs into electronic batch record/process automation technologies to advance digital manufacturing strategy
  • Assist in designing, testing, and maintaining Electronic Batch Records and related manufacturing data, including, but not limited to specifications, process parameters, recipes, routings, formulas, process instructions, and process variables.
  • Ensuring Recipes/MES are configured for intended use in accordance with business requirements and applicable procedures throughout the recipes and MES system lifecycle from design to implementation.
  • Translate business requirements into functional and design specifications which is compliant, efficient, and effective.
  • Participate on project teams to help prepare project schedules, execute technical projects and develop presentations to disseminate results to project stakeholders and senior management.
  • Support the change initiatives and the implementation of process improvement initiatives.
  • Foster strong inter-team relationships to achieve common project goals.
  • Interface with operations and serve as process SME
  • Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production.
  • Execute test plans and other risk mitigation exercises as part of investigations (e.g. Root cause analysis and CAPAs).
  • Organize, record and maintain experimental data.
  • Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
  • Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records).
  • Interact with other teams including Validation, Development, Operations, QA and Regulatory.
  • Participate in routine plant operating meetings.
  • Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
  • Support health authority inspections
  • Ability to set priorities, manage timelines and effectively react/manage changing priorities.
  • Ability to work with management (global and site) and support corporate and departmental goals.
  • Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers.
  • Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control. Proven delivery of complex investigation reports.
  • Ability to train and mentor junior associates to foster and develop their expertise.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  • Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus.
  • Knowledge of the relationship between manufacturing processes, ERP, and MES a major plus
  • Must have excellent organization skills and ability to handle multiple tasks
  • Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
  • Possess strong verbal/written communication skills.
  • Ability to think strategically and to translate strategy into actions.

Education and Experience:

  • Bachelor’s Degree required (science or engineering is preferred)
  • 5+ years of relevant experience.

BMSCART

#LI-Hybrid

VETERAN

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 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/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.




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