A Mechanical Engineer researches, designs, develops, constructs, and tests mechanical devices including machines, engines and tools. Works on devices ranging from power generators to household dishwashers to surgical equipment. May specialize in a particular type of machine or tool. May develop new devices or improve existing ones to run more efficiently.
Equipment Commissioning & Qualification (CQV) Engineer SOKOL GxP Services - 5.0 Summit, NJ Job Details Contract $115,856 - $126,256 a year 12 hours ago Benefits Paid holidays Health insurance Dental insurance 401(k) Vision insurance Referral program Qualifications Quality control corrective actions Report preparation Microsoft Excel GAMP Contractor management Microsoft Outlook Requirements specification Requirements design Laboratory equipment performance testing and validation Pharmaceutical regulatory compliance Laboratory instrument validation Vendor coordination Production deviation management Good documentation practices (GDP) Corrective and preventive actions (CAPA)
FDA 21 CFR
Part 11 Change management Production validation processes Quality assurance experience within pharmaceutical industry Vendor relationship management Biomedical regulatory compliance Investigating compliance violations Commissioning phase involvement Pharmaceutical manufacturing facility experience SDLC Database software proficiency Full Job 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 a GMP-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.
Preferred:
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.
