Equipment CQV Project Lead (GMP/Lab Systems)

Bristol-Myers Squibb Co; Summit (NJ); On-site; USD 107,000 - 129,000; Full time

Benefits offered by this job

Flexible Time Off

Comprehensive benefits

Wellbeing & retirement plans

Job summary

Bristol Myers Squibb is seeking a Project Engineer/Manager for ECQ Delivery to ensure operation of QC labs, manufacturing and support equipment at a multi-product site. You will coordinate projects, schedule activities, and lead project teams in a fast-paced GMP environment.

The role requires strong cGMP knowledge, regulatory exposure, and the ability to train staff while maintaining safety, timelines, and budget. Shift is Mon-Fri 8AM-5PM; on-site work at Summit, NJ.

Qualifications

• BS in Engineering or related science; degree may be substituted with experience.
• 7+ years' experience in pharmaceutical validation in GMP environments.
• 3.5+ years' experience managing personnel and/or projects.
• Strong instrumentation background in laboratory and manufacturing operations.
• Experience interacting with regulatory auditors in a compliance setting.
• Thorough knowledge of cGxP, CFR 21 Part 11, and CSV practices.

Responsibilities

• Leads multiple project teams and coordinates contractor resources.
• Oversight of Commissioning, Qualification, and Validation activities for equipment, facilities, and utilities.
• Develops and reviews SOPs, work plans, and validation deliverables; ensures regulatory alignment.
• Ensures safety, training, and performance of project staff; tracks timesheets and workload balance.
• Interacts with customers to manage expectations and maintain relationships.
• Maintains timelines and budgets across projects; communicates status to stakeholders.

Skills

Project management

Leadership

Regulatory knowledge

cGMP knowledge

Communication

Budgeting

Multi-project management

Education

BS in Engineering or science

Tools

CMMS

Computerized validation

GxP software

Job description

Bristol Myers Squibb is seeking a Project Engineer/Manager for ECQ Delivery to ensure operation of QC labs, manufacturing and support equipment at a multi-product site. You will coordinate projects, schedule activities, and lead project teams in a fast-paced GMP environment.

The role requires strong cGMP knowledge, regulatory exposure, and the ability to train staff while maintaining safety, timelines, and budget. Shift is Mon-Fri 8AM-5PM; on-site work at Summit, NJ.