Senior Specialist, CTO MSAT Process Validation Engineer II - S12

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: careers.bms.com/working-with-us.

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 Part11 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 21CFR Part 11 compliant electronic systems.
• Provide technical input, lead validation related deviations and investigations, perform root cause analysis and implement CAPAs, ensuring compliance with validated state of the manufacturing process.
• Supports and assesses site validation impacts to change initiatives and the implementation of process improvement initiatives via CAPAs and Change Controls to identify requirements necessary to maintain validated status.
• Author and support validation risk assessments for existing and new/changed processes.
• Must be able to work in controlled environments requiring clean room gowning in ISO 5, ISO 7, and ISO 8 areas.
• Is recognized Subject Matter Expert (SME) within the group.
• Support process validation deliverables for Health Authority (HA) regulatory submissions and inspections, maintaining permanent inspection readiness for process validation.
• Support stakeholders in accomplishing productivity goals with internal and external cross- functional teams.

Leadership Attributes:

• 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
• 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

Qualifications:

• Expert knowledge of good manufacturing practices (GMP) and quality systems concepts.
• Familiarity with 21 CFR Part 11, cell therapy/ biopharmaceutical industry guidelines and/or health authority (HA) regulations and associated compliance documentation (e.g. FDA, EMA, Health Canada, IGJ, etc).
• Deep knowledge of manufacturing facility and clean room designs, cell therapy processes, equipment, automation, and validation activities.
• Hands-on experience with single-use technologies, closed systems, and cell therapy technologies.
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities and cell therapy products.
• Sound scientific understanding of process validation principles and design.
• Experience with Change Controls, CAPAs, Deviations, standard operating procedures (SOPs), protocols and reports.
• Effectively communicates with internal and external cross-functional teams and represents department in collaborations to drive successful completion of projects within defined timelines across the cell therapy division and network.
• Must have strong authorship skills and be able to critically review protocols, investigations, deviations, reports, interpret results, and generate technical conclusions consistent with fundamental scientific knowledge, GMP and Good Documentation Practices (GDocP).
• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
• Ability to work independently with minimal direction to completes tasks, ability to obtain resources and information from established internal contacts; consults with supervisor for decisions outside established processes; authority to make daily decisions in support of team goals.
• Ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Possesses strong leadership skills in a multi-project industry setting.

Education/Experience/ Licenses/Certifications:

• Bachelor’s Degree required (science or engineering is preferred), Advanced Degree is a plus.
• 3 or more years of manufacturing support or related experience in the biopharmaceutical industry.
• 1 or more years of experience leading or executing process validation activities.
• Equivalent combination of education and experience acceptable.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Summit West - NJ - US: $86,490 - $104,803


The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

​Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in 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.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1602731 : Senior Specialist, CTO MSAT Process Validation Engineer II - S12