Bristol Myers Squibb Company

Associate Bioengineer - Process Validation

Location
Summit West, NJ, United States
Posted
Sep 03, 2020
Ref
R1529377
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.

PURPOSE AND SCOPE OF POSITION:

Position Summary

The Associate Process Validation Engineer I, CAR T is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. The Associate Process Validation Engineer I develops qualification/ validation documents (e.g. protocols and reports) satisfying internal and external regulatory expectations. He/she perform independent execution of validation activities required for the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Responsibilities include, but are not limited to, the following:
  • Ensure safe and compliant cGMP operations.
  • Maintain permanent inspection readiness and actively support regulatory inspections.
  • Interface with operators and serve as validation SME. Learn the procedures, analytics and document any known sensitivity.
  • Follow the facility validation policy and validation master plan.
  • Support the GMSAT Validation department in the development and implementation of programs for the facility that ensure all aspects of the validation program are maintained in a state of compliance with respect to corporate and regulatory standards.
  • Coordinate department validation activities within the production schedule.
  • Develop the protocols for routine and extraordinary qualification, validation, re-qualification and revalidation of equipment and process.
  • Support site Process Validation activities including, but not limited to, Aseptic Process Simulations/ Validations (APS/APV), Process Performance Qualifications (PPQ), Dynamic Airflow Visualization Studies, Container Closure Integrity Testing (CCIT), etc.
  • Authors Regulatory filing Sections to support Clinical Manufacturing, Commercialization and Lifecycle management
  • Conduct training for internal customers on protocols associated with equipment, systems, and processes under validation.
  • Perform investigations associated to validation activities (e.g. deviations or OOS during validation studies).
  • Perform data analysis, including the use of statistics, and prepare written reports/summaries from validation studies
  • Provide technical input and investigation support for production related investigations, ensuring compliance with validated state of the process.
  • Support change initiatives and the implementation of process improvement initiatives by assessing the impact to the validated state of the process.
  • Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records) ensuring compliance with validated state of the process.
  • Interact with other teams including Process Engineering and Support, Development, Operations, QA and Regulatory
  • Interface with regulatory authorities as required to support Manufacturing Operations audits.
  • Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
  • Foster strong inter-team relationships to achieve common project goals
  • Support the tracking of team metrics and manage completion of objectives and projects
  • Participate in routine plant operating meetings


Leadership:
  • 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
  • Promote a mindset of continuous improvement, problem solving, and prevention


REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
  • Expert knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations
  • Deep knowledge of facility/clean room design, process, equipment, automation, and validation
  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
  • Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
  • Experience working with external parties and/or leading cross-functional teams
  • Possess strong verbal/written communication skills and ability to influence at all levels
  • Ability to think strategically and to translate strategy into actions
  • Ability to prioritize and provide clear direction to team members in a highly dynamic environment
  • Experience with Operational Excellence and Lean Manufacturing

Education and Experience:
  • Bachelor's Degree required (science or engineering is preferred)
  • 0-1 year of manufacturing support or related experience in the biopharmaceutical industry


WORKING CONDITIONS (US Only):

**In the above field, describe environment (e.g. lighting and temperature), conditions (e.g. noise-level and air quality), available equipment, required physical activity (e.g. maximum weight to be lifted/carried, percent of time seated, standing, or walking).**

Do not include red instructional text in final document.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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.