QC Equipment Lifecycle Specialist - Cell Therapy

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

Job summary

Bristol Myers Squibb is seeking a Senior Specialist to manage the lifecycle activities of QC laboratory equipment and may serve as the QC equipment system owner.

You will collaborate with QC laboratories, Site Engineering, Facility Services and other departments for commissioning and decommissioning, perform qualification, calibration, maintenance, repairs, and maintain equipment records. This role reports to QC management and offers competitive compensation and comprehensive benefits.

Qualifications

• Understand and apply global regulatory and cGMP requirements.
• 4+ years of relevant lab experience in a regulated environment.
• Experience with equipment qualification and validation.
• Proficiency with SAP, Valgenesis and Maximo is preferred.

Responsibilities

• Manage lifecycle activities of QC laboratory equipment.
• Create equipment User Requirements, validation protocols and related documents.
• Collaborate with QC labs, Site Engineering and Facility Services on commissioning/decommissioning.
• Schedule, perform qualification, calibration, maintenance, repairs of QC equipment.
• Maintain equipment records, logs and status metrics in GMP-compliant manner.
• Troubleshoot problems and solve issues with minimal guidance.
• Train and mentor others on lifecycle processes.
• Review GMP documents and vendor validation documents for GDP adherence.
• Support QC labs with related tasks as needed.

Skills

Problem solving

Communication

Teamwork

Technical writing

GMP knowledge

Education

Bachelor's degree in science

Advanced degree preferred

MLO level 4 (Netherlands)

Tools

SAP

Valgenesis

Maximo

Job description

Bristol Myers Squibb is seeking a Senior Specialist to manage the lifecycle activities of QC laboratory equipment and may serve as the QC equipment system owner.

You will collaborate with QC laboratories, Site Engineering, Facility Services and other departments for commissioning and decommissioning, perform qualification, calibration, maintenance, repairs, and maintain equipment records. This role reports to QC management and offers competitive compensation and comprehensive benefits.