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Bristol-Meyers Squibb, Co.

Specialist, Engineer I Process Validation (R1546421-en-us)

Pharmaceuticals

All

Yearly

No

Summit, New Jersey, United States

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.

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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

Position Summary

The Specialist, Engineer I - Process Validation, is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. The Process Validation Engineer 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 CAR T 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.

  • 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

  • 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).

  • 3 or more years of manufacturing support or related experience in the biopharmaceutical industry.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART

VETERAN

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 . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

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