Senior Specialist, QC Support, Cell Therapy

Bristol Myers Squibb; United States; On-site; USD 91,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Flexible Time Off

Paid holidays

Disability insurance

Job summary

Bristol Myers Squibb is hiring a Senior Specialist to manage the lifecycle activities of QC laboratory equipment at Devens, MA. You may serve as the QC equipment system owner, ensuring GMP-compliant documentation and calibration processes.

Responsibilities include creating validation protocols, coordinating with cross-functional teams, and maintaining records and equipment databases in a regulated environment. This role reports to QC management and offers comprehensive benefits.

Qualifications

• Understand and apply Global Regulatory and cGMP requirements.
• Demonstrate strong problem-solving and technical writing skills.
• Communicate task status with cross-functional teams.
• Work well in a fast-paced team and meet deadlines.

Responsibilities

• Manage lifecycle activities of QC lab equipment.
• Create equipment User Requirements and validation documents.
• Collaborate with QC labs, Site Engineering, Facility Services for commissioning/decommissioning.

Skills

Regulatory compliance

cGMP knowledge

Documentation

Communication

Education

Bachelor’s degree in science

Advanced degree preferred

Tools

SAP

Valgenesis

Maximo

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The Senior Specialist position manages the lifecycle activities of QC laboratory equipment. May serve as the QC equipment system owner.

Duties/Responsibilities

• Manage the lifecycle activities of QC laboratory equipment. May serve as the QC equipment system owner.
• Create equipment User Requirement, validation protocols and equipment related documents.
• Collaborate with QC laboratories, Site Engineering, Facility Services, and other departments for the commissioning and decommissioning of laboratory equipment.
• Schedule, facilitate and participate in performing the qualification, calibration, maintenance, repairs of QC laboratory equipment, whether performed internally or by vendors.
• Maintain equipment records in accordance with GMP requirements and written procedures.
• Maintain electronic equipment database, equipment logs, equipment status metrics, and applying equipment status labels.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Train and mentor others on equipment lifecycle process and procedures as applicable.
• Perform document revision, project, CAPA and deviation/ investigation, change management actions, related tasks and/ or continuous improvement efforts.
• Review GMP documentation/ records, including vendor executed validation documents for GDP adherence.
• Perform other tasks as required to support the QC laboratories.

Reporting Relationship

• This position will report to QC management.

Qualifications

Specific Knowledge, Skills, Abilities :

• Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Bachelor’s degree or equivalent required, preferably in science.
• Advanced degree preferred. Netherlands: MLO level 4 required.4+ years of relevant laboratory experience or equivalent combination of education and experience, preferably in a regulated environment.
• Advanced knowledge of computerized systems and enterprise applications such as SAP, Valgenesis and Maximo preferred.
• Demonstrated technical writing skills.
• Working knowledge of data integrity principles preferred.
• Demonstrated experience with equipment qualification and validation.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Devens - MA - US: $91,180 - $110,488

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only:

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/

For roles based in Washington State only:

If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

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 this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.