QC Equipment Lifecycle Lead, Cell Therapy

Bristol-Myers Squibb Company; Harvard (MA); On-site; USD 91,000 - 110,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Vacation time

Wellbeing support

Job summary

Bristol Myers Squibb Company in Devens, MA is seeking a Senior Specialist to manage the lifecycle activities of QC laboratory equipment and potentially serve as the QC equipment system owner. The role involves creating user requirements, protocols, and coordinating with QC laboratories, Site Engineering and Facility Services for equipment commissioning and decommissioning.

The ideal candidate has 4+ years in a regulated lab environment, strong regulatory knowledge, and experience with SAP,

Qualifications

• Bachelor’s degree or equivalent is required, preferably in science.
• Advanced degree preferred.
• 4+ years of relevant laboratory experience in a regulated environment.
• Advanced knowledge of computerized systems and enterprise applications such as SAP, Valgenesis and Maximo preferred.

Responsibilities

• Manage lifecycle activities of QC laboratory equipment and act as equipment system owner.
• Create equipment user requirements, validation protocols, and related documents.
• Collaborate with QC labs, Site Engineering, Facility Services for commissioning/decommissioning equipment.
• Schedule, facilitate, and perform qualification, calibration, maintenance, and repairs by internal teams or vendors.
• Maintain GMP-compliant equipment records and logs; monitor metrics and status labels.
• Train and mentor others on equipment lifecycle processes and change management tasks.
• Review GMP documentation and vendor validation documents for GDP adherence.

Skills

Regulatory knowledge

Problem solving

Communication

Team collaboration

Education

Bachelor’s degree in science

Advanced degree preferred

Tools

SAP

Valgenesis

Maximo

Job description

Bristol Myers Squibb Company in Devens, MA is seeking a Senior Specialist to manage the lifecycle activities of QC laboratory equipment and potentially serve as the QC equipment system owner. The role involves creating user requirements, protocols, and coordinating with QC laboratories, Site Engineering and Facility Services for equipment commissioning and decommissioning.

The ideal candidate has 4+ years in a regulated lab environment, strong regulatory knowledge, and experience with SAP,