Lead Equipment Qualification & Validation Engineer

VetJobs; New Jersey; On-site; USD 75,000 - 100,000; Full time

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Lead Engineer for Equipment Commissioning and Qualification (ECQ) Delivery. The role supports equipment, utilities, facility, and lab instrument projects at multi-use sites, coordinating with internal and external teams to ensure timely and compliant execution.

Responsibilities include managing qualification projects, developing validation deliverables, and overseeing contract project teams to meet compliance standards.

Qualifications

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11 and computer systems validation requirements.
• Experience with pharmaceutical manufacturing and laboratory systems.
• Strong written and verbal communication skills.

Responsibilities

• Maintain qualified equipment systems in compliance with policies and procedures.
• Develop qualification protocols and reports with change control.
• Manage equipment implementation projects from scheduling to turnover to business area.
• Provide technical support for qualification and validation issues and CAPA management.

Skills

cGMP/GXP knowledge

Project management

Regulatory compliance

Technical communication

Database & data systems

Quality systems understanding

Education

BS in Engineering or Science

Tools

Microsoft Office Suite

Database systems

Job description

Bristol Myers Squibb in Summit, NJ is seeking a Lead Engineer for Equipment Commissioning and Qualification (ECQ) Delivery. The role supports equipment, utilities, facility, and lab instrument projects at multi-use sites, coordinating with internal and external teams to ensure timely and compliant execution.

Responsibilities include managing qualification projects, developing validation deliverables, and overseeing contract project teams to meet compliance standards.