Senior Equipment Commissioning & Qualification Lead

1010 Celgene - Summit (Corp); New Jersey; On-site; USD 107,000 - 129,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work options

Job summary

Bristol Myers Squibb is seeking a Project Engineer/Manager, Equipment Commissioning & Qualification Delivery, to oversee QC labs, manufacturing and support services equipment at a multi-product site. You will coordinate multiple projects, manage staff, and balance schedules and budgets while performing hands-on work as needed.

The role emphasizes cGMP, GXP, 21 CFR part 11, and validation activities, with a Monday–Friday schedule 8AM-5PM.

Qualifications

• BS in Engineering or science-related discipline preferred.
• 7+ years of pharmaceutical validation experience in GMP.
• Experience managing personnel and/or projects.
• Strong knowledge of cGMP, GXP, SDLC and 21 CFR Part 11.

Responsibilities

• Leads multiple project contractors and project teams.
• Coordinates CQV activities for equipment, facilities and systems.
• Manages project schedules, budgets and resources.
• Ensures training, safety and compliance across sites.
• Interacts with regulatory agents and internal auditors.

Skills

Project management

Leadership

Regulatory compliance

Communication

cGMP/GxP knowledge

Validation expertise

Planning and scheduling

Team coordination

Education

BS in Engineering or science-related discipline

Minimum 7 years pharma validation experience

Tools

CMMS

Validation software

Job description

Bristol Myers Squibb is seeking a Project Engineer/Manager, Equipment Commissioning & Qualification Delivery, to oversee QC labs, manufacturing and support services equipment at a multi-product site. You will coordinate multiple projects, manage staff, and balance schedules and budgets while performing hands-on work as needed.

The role emphasizes cGMP, GXP, 21 CFR part 11, and validation activities, with a Monday–Friday schedule 8AM-5PM.