Senior Specialist, CTO MSAT Process Validation Engineer II - S12 Summit West - NJ - US R1602731

Position: Senior Specialist, CTO MSAT Process Validation Engineer II - S12 Summit West - NJ - US R1602731[...]
## Senior Specialist, CTO MSAT Process Validation Engineer II - S12

Summit West - NJ - USFind out how well you match with this job
** Working with Us
** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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. Read more:
*
* Position Summary:

** The Senior Specialist, CTO MSAT Process Validation Engineer II is responsible for supporting the production of personalized cell therapy products for global clinical trials and commercial supply in the CTO Summit, NJ manufacturing site.  The Senior Specialist develops and supports qualification and validation activities in a leading role (e.g. protocols, reports, site procedures and batch records, and agency filing content) satisfying internal and external regulatory expectations.

The Senior Specialist will collaborate with Global MSAT as well as Product and Development, Manufacturing Operations (MO), Supply Chain (SC), Quality Control (QC) and Quality Assurance (QA) departments while providing technical support for the resolution of validation related project deliverables, evaluation and implementation of process changes and continuous process improvement support to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

** Duties/Responsibilities:**·  
* Support CAR-T manufacturing 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), Continued Process Verification (CPV) programs and revalidation strategies to meet GMP deadlines, to ensure that the programs are compliant with regulatory agencies requirements.
* Execute all responsibilities to meet cGMP and 21 CFR Part
11 data integrity requirements and ensure validation activities are maintained in a state of control and compliance.
* Contributes to development of process validation strategies, protocols, SOPs, and batch records for Cell Therapy manufacturing processes as well as data analysis and compilation of results.
* Ensure process validation standards, site validation master plans, process qualification strategies and CPV strategies are implemented consistently and support execution and closure of validation activities.
* Collaborate with internal and external cross-functional teams for validation executions, tech transfers, and new product launches to ensure that knowledge is transferred, control strategies are appropriate, and risks are analyzed to ensure that commercial processes are validation ready.
* Support process validation lifecycle activities by ensuring a state of control is maintained through CPV programs.
* Coordinate and collaborate with other departments (e.g., Process Engineering (PE), Facilities, Manufacturing Operations (MO), Quality Control (QC), Quality Assurance (QA), Supply Chain (SC) and Regulatory) to ensure achievement of objectives relating to process validation executions and associated activities, including compliance with all applicable standards.
* Leads APS/APV, PPQ and validation projects by providing technical oversight, coordinate preparation, training execution and oversight, and report closures throughout the product life cycle.
* Author, review and approve process validation protocols and reports, data retrieval, compilation, and verification from a variety of 21

CFR Part 11…