Equipment Commissioning & Qualification (CQV) Engineer
About The Position
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.
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
- 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
Nice To Haves
- Bachelor’s degree in Engineering or a science-related discipline; sufficient relevant experience may substitute for the degree
- Experience with ValGenesis
Responsibilities
- Develop and execute commissioning and qualification protocols
- Prepare validation and qualification documentation
- Coordinate external vendors
- Support equipment implementation from site preparation and installation through qualification and turnover
- Support change management
- Support equipment lifecycle activities
- Support technical troubleshooting
- Support deviation investigations
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
