Senior Specialist, QC Support, Cell Therapy

Bristol Myers Squibb • Devens, MA

4d

About The Position

The Senior Specialist manages the lifecycle activities of QC laboratory equipment and may serve as a QC equipment system owner. The role supports QC laboratories by coordinating equipment documentation, qualification, calibration, maintenance, troubleshooting, and compliance activities. It also involves collaboration with internal departments and vendors, maintaining equipment records and systems, and contributing to quality and continuous improvement work.

Requirements

• Ability to accurately and completely understand, follow, interpret, and apply global regulatory and cGMP requirements.
• Strong problem-solving ability, technical aptitude, and logical reasoning.
• 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; an advanced degree is preferred.
• For Netherlands-based applicants, MLO level 4 is required.
• At least 4 years of relevant laboratory experience, or an equivalent combination of education and experience; experience in a regulated environment is preferred.
• Demonstrated technical writing skills.
• Demonstrated experience with equipment qualification and validation.

Nice To Haves

• Advanced degree.
• Relevant laboratory experience in a regulated environment.
• Advanced knowledge of computerized systems and enterprise applications such as SAP, ValGenesis, and Maximo.
• Working knowledge of data integrity principles.

Responsibilities

• Manage the lifecycle activities of QC laboratory equipment and potentially serve as a QC equipment system owner.
• Create equipment user requirements, validation protocols, and equipment-related documents.
• Collaborate with QC laboratories, Site Engineering, Facility Services, and other departments on commissioning and decommissioning laboratory equipment.
• Schedule, facilitate, and participate in equipment qualification, calibration, maintenance, and repairs performed internally or by vendors.
• Maintain equipment records in accordance with GMP requirements and written procedures.
• Maintain the electronic equipment database, equipment logs, equipment status metrics, and equipment status labels.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Train and mentor others on equipment lifecycle processes and procedures, as applicable.
• Perform document revisions and tasks related to projects, CAPA, deviations and investigations, change management, and continuous improvement.
• Review GMP documentation and records, including vendor-executed validation documents, for GDP adherence.
• Perform other tasks as required to support the QC laboratories.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval, or paid vacation for specified employee groups.
• 11 paid company holidays each year; certain employee groups also receive 3 optional holidays.
• Depending on eligibility, 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 may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior