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Aseptic Process Validation Engineer

Bristol-Myers Squibb Company

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Devens, MA
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Job Description

As posted by the hiring company

Job Overview:

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.

Position Summary

The Process Validation Engineer supports the aseptic process simulation and validation program for the Devens Cell Therapy Facility. The Process Validation Engineer reports to the Associate Director, Process Engineering within the site Manufacturing Sciences and Technology organization.

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

  • Supports site Process Validation activities including, but not limited to, Aseptic Performance Qualification and Aseptic Process Simulations/ Validations (APS/APV), Process Performance Qualifications (PPQ), Dynamic Airflow Visualization Studies.
  • Participate in facility risk assessments, author technical documents (e.g. procedures, protocols and reports) in accordance with internal and external regulatory expectations.
  • Ensure safe and compliant cGMP operations.
  • Maintain permanent inspection readiness and actively support regulatory inspections.
  • Interface with operators and serve as an aseptic validation SME.
  • Coordinate department validation activities within the production schedule.
  • Conduct training 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
  • Support change initiatives and the implementation of process improvement initiatives by assessing the impact to the validated state of the process.
  • Interact with other teams including Process Engineering and Support, QC Microbiology, Manufacturing Operations, and Quality Assurance
  • Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.

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 incident prevention

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

  • Subject Matter Expert in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g FDA) related to the design and control of the aseptic/environmental aspects of these processes.
  • Experience in sterile manufacturing plant(s) with interaction regarding the EM programs, gowning practices, media fill program, and/or sterilization practices and aseptic technique.
  • Proficient in facility/clean room design, process, equipment, automation, and validation
  • Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
  • Experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
  • Experience working with external parties and/or leading cross-functional teams
  • Excellent 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).
  • Minimum 4 years relevant experience in GMP biologic manufacturing technical or process support.
  • Validation experience is required, aseptic process validation experience is preferred.

WORKING CONDITIONS:

  • Position may require working in Clean-Room manufacturing environment approximately 15% of the time. Remainder of work is performed in an office environment.
  • 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.
  • 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.

BMSCART

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.