CQV Specialist I

Commissioning, Qualification & Validation (CQV) Specialist I

Raritan, NJ (Onsite)

Contract | $30-35/hour W2, potential conversion or extension

We're seeking a CQV Specialist to support commissioning, qualification, and validation activities in a GMP cell therapy manufacturing environment. This role is ideal for someone with hands-on validation experience who enjoys working cross-functionally to ensure compliant manufacturing operations and support production readiness.

Responsibilities

• Execute commissioning, qualification, requalification, and validation activities for facilities, equipment, utilities, and computerized systems
• Author, execute, and review CQV protocols, reports, and validation documentation
• Support investigations, deviations, CAPAs, change controls, and remediation activities
• Participate in risk assessments, FMEAs, periodic qualifications, and validation master plans
• Coordinate with engineering, manufacturing, quality, and external vendors to support multiple CQV projects
• Ensure validation activities are performed in accordance with cGMP requirements and data integrity standards

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
• 2-4+ years of CQV, validation, or engineering experience in a GMP pharmaceutical or biotechnology environment
• Experience authoring and executing validation documentation
• Strong knowledge of cGMP regulations and validation lifecycle activities
• Experience with change controls, deviations, CAPAs, and risk assessments
• Familiarity with 21 CFR Parts 210, 211, and 1271
• Experience with TrackWise, Maximo, CMMS, or similar systems is a plus
• Strong communication and organizational skills with the ability to manage multiple priorities

Preferred Experience

• Cell Therapy Unit (CTU) experience strongly preferred
• Cell & gene therapy manufacturing
• Aseptic manufacturing environments
• Good Tissue Practices (cGTP)
• Equipment, utility, facility, or computer system validation (CSV)

Compensation: $30-35/hour W2

• If you're looking to contribute to cutting-edge cell therapy manufacturing while expanding your CQV experience, we'd love to connect.

This job opens for applications on 7/8/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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