Job Description

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 Sr. Manager, Sr Process Validation Engineer is responsible for the aseptic process simulation and validation program for the Devens Cell Therapy Facility. The Sr. Process Validation Engineer reports to the Director of Manufacturing Technology and will create the program to support facility start up, initial validation, and ongoing GMP operations.

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

Technical:

* Responsible for 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.
* Create the facility validation policy and validation master plan.
* Participate in facility risk assessments, author qualification/ validation documents (e.g. 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 the facilitys aseptic validation SME.
* Coordinate department validation activities within the production schedule.
* 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, 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:

* Expert knowledge of cGMPs and multi-national biopharmaceutical/cell therapy regulations
* Expert knowledge of facility/clean room design, process, equipment, automation, and validation
* Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
* 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.
* 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:

* o Bachelors Degree required (science or engineering is preferred).
* o Minimum 8 years of industry experience with a minimum of 6 years of experience in an aseptic process environment.
* o Aseptic process qualification, validation experience is required.

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.

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 any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.