Senior Specialist

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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

Position Summary

The Senior Specialist supports the successful operation of facilities, laboratories, and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers.  The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Process Equipment projects and ongoing work activities of low to moderate complexity, individually and with support of others.  The incumbent spends most of their time on individual work.  The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.  The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short‐term projects according to established policies and procedures.

Role & Responsibilities:

The Senior Specialist supports the Commissioning, Qualification, and Validation team as an individual contributor to:

CQV Deliverables

• Author, review, approve, and execute equipment qualification protocols, plans, summary reports, protocol deviations, and other validation deliverables as required.
• Author, review, and approve equipment risk assessments, system categorization assessments, and change control impact assessments.
• Propose, present, and execute change controls for equipment introduction, modification, and retirement.  Provide input and feedback for change strategy, qualification approach, compliance gaps, and risk mitigation.
• Review and approve calibration plans, preventative maintenance schedules, system criticality/classification assessments, alarm assessments, and asset change requests within the computerized maintenance management system.

System Ownership

• Procure new CQV equipment and implement associated procedures to support process equipment qualifications.  Train new users to operate CQV equipment and troubleshoot as needed.
• Create, revise, and periodically review procedural documents for CQV equipment such as temperature and humidity mapping systems, CO2 instruments, and LN2 foggers.
• Coordinate system usage to maintain CQV timelines while adhering to system calibration and maintenance schedules.
• Perform data integrity risk assessments, audit trail reviews, and user access reviews for CQV equipment.

Compliance and Regulatory Responsibilities

• Lead and support workflows related to quality events and actions including deviations, investigations, proactive initiatives, and corrective and preventive actions.
• Create, revise and periodically review CQV program SOPs and associated work instructions/practices.
• Administer and perform system periodic reviews and CQV document periodic reviews, and review/approve corresponding deliverables.  Periodically update the CQV validated systems list.
• Ensure manufacturing and laboratory equipment is maintained in a validated state in compliance with GMP, BMS standards, and health authority regulations.  Serve as a subject matter expert for equipment qualification in internal and regulatory audits.

Qualifications & Experience

The Senior Specialist contributes essential skills, competencies, and experience necessary for equipment commissioning and qualification, including:

• BS in an Engineering/Science discipline required or minimum of 5 years of experience leading equipment qualifications.  
• 3+ years of experience in FDA-regulated industry.
• 3+ years of experience developing and executing equipment qualifications, process validations, and/or test method validations.
• Strong background and experience in laboratory and manufacturing operations, with advanced knowledge of cGMP pharmaceutical manufacturing and associated process equipment utilized for cell therapy clinical manufacturing.
• Experience executing temperature/humidity mapping qualifications for controlled storage areas and/or controlled temperature units (incubators, refrigerators, freezers, cryogenic storage systems) is required.
• Highly preferred experience designing and performing airflow visualization studies for biological safety cabinets, isolators, and controlled/classified areas.
• Preferred experience commissioning and qualifying isolators and filling/capping equipment, with a technical background and basic understanding of operation and changeover of aseptic fill/finish technology.
• Process oriented with strong problem solving and critical thinking skills.  Adaptive and able to develop new and improved strategies, approaches, and procedures.
• Excellent technical writing skills and proficiency with Microsoft Word formatting functions.  Detail oriented and technically accurate author and reviewer of documents for system lifecycle deliverables in alignment with the site validation program.  Highly attentive to spelling, grammar, punctuation, and overall document quality.
• Strong multi‐tasking ability in conjunction with proven organizational skills.  Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks and assignments with others that may impact timely completion.  Independently and effectively manage multiple tasks and activities simultaneously.
• Excellent communication and interpersonal skills; communicate effectively, efficiently, and in a timely manner.  Experience dealing with a diverse workforce; team oriented and professionally mature.
• Highly proficient in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook.  Working knowledge of scheduling software, material inventory management systems, calibration/maintenance management systems, and environmental monitoring systems.
• Strong understanding of quality management systems, document management systems, records management, and data integrity principles.
• Experience interacting with external and/or internal auditors in a compliance audit environment, with direct interaction including face to face interaction in response to audit questions is preferred.

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.

Warren - 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 then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition 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.

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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/

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