QC Equipment Lifecycle Specialist - Cell Therapy

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

Job summary

Bristol Myers Squibb is seeking a Senior Specialist to manage QC equipment lifecycle activities and serve as the system owner for QC equipment. You will create user requirements, validation protocols, and essential documentation while coordinating with QC labs, Site Engineering, and Facility Services.

The role requires 4+ years in a regulated lab, strong knowledge of cGMP, and experience with SAP/Valgenesis/Maximo.

Qualifications

• 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.
• 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.
• Knowledge of cGMP and regulatory requirements.

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.

Skills

Regulatory knowledge

Problem solving

Communication

Teamwork

Technical writing

Data integrity

Equipment qualification

Quality systems

Education

Bachelor’s degree or equivalent

Advanced degree preferred

MLO level 4 (Netherlands)

Tools

SAP

Valgenesis

Maximo

Job description

Bristol Myers Squibb is seeking a Senior Specialist to manage QC equipment lifecycle activities and serve as the system owner for QC equipment. You will create user requirements, validation protocols, and essential documentation while coordinating with QC labs, Site Engineering, and Facility Services.

The role requires 4+ years in a regulated lab, strong knowledge of cGMP, and experience with SAP/Valgenesis/Maximo.