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