Associate Process Engineer I

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position Summary

Associate Process Engineer I, CAR-T 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 SME 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:


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.

Bachelor’s Degree required (science or engineering is preferred) with 0-2 years of relevant experience.


PREREQUISITES

Experience in biologic/vaccine manufacturing support, tech transfer, and validation

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

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