Equipment Commissioning & Qualification (CQV) Engineer

About the role

Support the implementation, qualification, validation, and continued compliant operation of equipment, instruments, facilities, and utilities at a GMP-regulated pharmaceutical site. Develop and execute commissioning and qualification protocols, prepare validation and qualification documentation, coordinate external vendors, and support equipment implementation from site preparation and installation through qualification and turnover. The role also supports change management, equipment lifecycle activities, technical troubleshooting, and deviation investigations as needed.

Location: Summit, New Jersey
Work arrangement: 100% onsite

Responsibilities

• Develop and execute commissioning and qualification protocols
• Prepare validation and qualification documentation
• Coordinate external vendors during equipment implementation
• Support equipment lifecycle activities, technical troubleshooting, and deviation investigations
• Manage change control and ensure compliance with GMP regulations
• Prepare qualification deliverables such as Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports

Requirements

• Minimum of 5 years of experience performing or supporting activities in a GMP-regulated environment
• Minimum of 3 years of experience in equipment, facilities, or utilities qualification
• Experience developing and executing commissioning, qualification, or validation protocols and associated reports
• Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, computerized systems validation requirements, and good documentation practices
• Understanding of investigations, deviations, CAPA, and change management in a regulated pharmaceutical environment
• Ability to supervise vendors and manage equipment implementation or qualification activities
• Ability to manage multiple projects, priorities, and assignments in a fast-paced environment
• Strong written, verbal, organizational, analytical, and interpersonal skills
• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and database systems
• Authorization to work in the United States without visa sponsorship

Qualifications

• Bachelor’s degree in Engineering or a science-related discipline (preferred; sufficient relevant experience may substitute for the degree)
• Experience with ValGenesis (preferred)

Pay

Hourly rate: $55.7–$60.7 (W-2 contract position, no C2C options)

Schedule

• Monday–Friday, normal business hours
• Maximum 40 hours per week
• Contract length: 6 months, with possible extension based on performance
• Start date: August 17, 2026

Benefits

• Health insurance with dental and vision options
• Holiday pay
• 401(k) program
• Employee referral bonus program