Associate Process Engineer I

Celgene, NJ, United States
Sep 17, 2020
Required Education
Bachelors Degree
Position Type
Full time
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.

CAR-T Process Engineering and Technology Support is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Manages multidiscipline projects, 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 for both global clinical trials and commercial supply.Collaborates with SMEs from the Development Group, Manufacturing Group, and Quality Group while running cross functional internal project teams from initiation through project closeout (e.g. he/she is the primary internal and external contact regarding the day-to-day execution of the project) in support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Responsibilities include, but are not limited to, the following:
  • Provide on the floor process support for ongoing manufacturing activities when needed.
  • With moderate supervision, design and execute/implement process experiments of moderate complexity.
  • 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.Learn the procedures, analytics, and document any known sensitivity.
  • 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 exercise 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.
  • Support the tracking of team metrics and manage completion of objectives and projects.
  • Participate in routine plant operating meetings.

Skills/Knowledge Required:
  • Bachelor's Degree required (science or engineering is preferred) with 0-2 years of relevant experience
  • Knowledge of cGMP's and multi-national biopharmaceutical regulations. Cell therapy experience is 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.

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.