Job Details
Posted 13 July, 2026
Job Id: 629132
CQV Specialist I – (Contract)
Job Description
Commissioning & Qualification (CQV) Specialist I – Contractor
Location: Somerset County, NJ (On-site)
Department: Technical Operations
Travel: Up to 5%
Position Summary
We are seeking a Commissioning & Qualification (CQV) Specialist I Contractor to support a cGMP clinical and commercial cell therapy manufacturing facility. This role will focus on the execution of core commissioning and qualification activities for controlled temperature units (CTUs), manufacturing/process equipment, laboratory/QC equipment, and supporting GMP systems.
The ideal candidate will have 2-4 years of hands-on CQV experience, specifically executing equipment and utility qualification activities in a GMP-regulated environment. Experience qualifying controlled temperature units, manufacturing/process equipment, and QC laboratory equipment is highly preferred.
This position will support protocol execution, discrepancy resolution, change management, investigations, and documentation activities while ensuring compliance with cGMP regulations and site procedures.
Key Responsibilities
- Execute commissioning, qualification, requalification, and validation activities for GMP facilities, utilities, equipment, and computerized systems.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
- Support qualification of:
- Controlled Temperature Units (CTUs)
- Manufacturing and process equipment
- QC laboratory equipment
- Associated GMP utilities and systems
- Author, review, and execute qualification protocols and summary reports.
- Coordinate qualification activities with Engineering, Manufacturing, Facilities, Quality, and external vendors.
- Support investigations, deviations, CAPAs, corrections, and remediation activities related to validated systems.
- Participate in change control assessments and implementation activities.
- Ensure all qualification documentation complies with site procedures, cGMP requirements, and data integrity expectations.
- Assist with risk assessments, FMEAs, periodic reviews, and validation lifecycle activities.
- Maintain inspection-ready documentation supporting GMP manufacturing operations.
Required Qualifications
Education
- Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.
Experience
- 2-4 years of hands-on Commissioning & Qualification (C&Q) experience required.
- Direct experience qualifying:
- Controlled Temperature Units (CTUs)
- Manufacturing/process equipment
- QC laboratory equipment
- Experience executing IQ/OQ/PQ protocols in a GMP-regulated environment.
- Experience supporting pharmaceutical, biotech, cell therapy, biologics, or medical device manufacturing operations preferred.
Required Skills & Knowledge
- Strong understanding of commissioning and qualification lifecycle activities.
- Working knowledge of cGMP requirements and validation principles.
- Experience with deviation management, investigations, CAPAs, and change controls.
- Ability to execute protocols independently and troubleshoot qualification issues.
- Strong technical writing skills and experience preparing qualification documentation.
- Familiarity with risk-based validation methodologies.
- Strong organizational, communication, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced manufacturing environment.
Preferred Qualifications
- Experience in cell therapy, CAR-T, biologics, or aseptic manufacturing environments.
- Knowledge of cGTP requirements.
- Experience with TrackWise, Maximo, and CMMS systems.
- Familiarity with 21 CFR Parts 210, 211, and 1271.
- Experience supporting GMP temperature mapping and CTU qualification activities.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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