Equipment Commissioning & Qualification (CQV) Engineer in Summit

Energy Jobline ZR; Summit (NJ); On-site; USD 77,000 - 84,000; Full time

Job summary

Energy Jobline ZR seeks an Equipment Commissioning & Qualification Engineer to support GMP-regulated site operations, with emphasis on commissioning, qualification, validation and continued compliant operation of equipment, instruments, facilities and utilities.

You will develop and execute commissioning/qualification protocols, prepare qualification deliverables, coordinate external vendors, and drive equipment implementation from site prep through turnover, while supporting change control and

Qualifications

• Minimum 5 years' experience in a GMP-regulated environment.
• Minimum 3 years' experience in equipment, facilities, or utilities qualification.
• Experience developing and executing commissioning, qualification, or validation protocols and associated reports.
• Experience preparing qualification deliverables such as Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
• Knowledge of 21 CFR Part 11, cGMP, GxP, SDLC, computerized systems validation requirements, and good documentation practices.
• Authorization to work in the United States without visa sponsorship.

Responsibilities

• Develop and execute commissioning and qualification protocols.
• Prepare validation and qualification documentation.
• Coordinate external vendors and support equipment implementation from site preparation to turnover.
• Support change management, equipment lifecycle activities, and deviation investigations.

Skills

GMP experience

Equipment qualification

Validation protocols

Documentation practices

Vendor management

Project management

Microsoft Office

Regulatory knowledge

cGMP knowledge

Education

Bachelor’s degree in Engineering or a science-related discipline

Tools

ValGenesis

Job description

Job DescriptionJob Description

We are seeking an Equipment Commissioning & Qualification Engineer to support the implementation, qualification, validation, and continued compliant operation of equipment, instruments, facilities, and utilities at aGMP-regulated pharmaceutical site.

The engineer will 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 will also support change management, equipment lifecycle activities, technical troubleshooting, and deviation investigations as needed.

Position details:

• Hourly rate: $55.7–$60.7;
• Contract length: 6 months, with possible extension based on performance;
• Start date: August 17, 2026;
• Location: Summit, New Jersey;
• Work arrangement: 100% onsite;
• Schedule: Monday–Friday, normal business hours;
• Maximum hours: 40 hours per week;
• W-2 contract position;
• No C2C options;
• No visa sponsorship.

Requirements

Required:

• 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;
• Experience preparing qualification deliverables such as Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports;
• Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, computerized systems validation requirements, and good documentation practices;
• Knowledge of pharmaceutical manufacturing and laboratory systems;
• 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.

:

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

Benefits

• Health insurance with dental and vision insurance options.
• Holiday pay.
• 401(k) program.
• Employee referral bonus program.
• Possible contract extension based on performance.
• The client retains the right to hire the contractor directly.