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Validation Engineer

Job

Voto Consulting LLC

Raritan, NJ (In Person)

Full-Time

Posted 3 days ago (Updated 10 hours ago) • Actively hiring

Expires 7/4/2026

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Job Description

Job Title:
Sr CQV/Validation Specialist Location:
Raritan New Jersey 100% onsite
Duration:
2+
Years Interview:
2
Virtual Interviews Job Description:
We are seeking a Senior CQV Specialist to lead commissioning, qualification, and validation activities for facility, equipment, and computerized systems supporting GMP cell therapy manufacturing. This individual will own qualification strategy and execution, ensuring compliant, risk ‑ based validation aligned with USP <1058>, GAMP 5, and industry best practices. Requirements 8+ years of CQV/validation experience in GMP pharmaceutical, biotech, or cell therapy manufacturing (cell therapy strongly preferred). Hands-on experience qualifying facility, equipment, and computerized systems. Strong working knowledge of USP <1058>, GAMP 5, and risk ‑ based validation methodologies. Demonstrated experience owning validation programs, writing protocols, executing testing, and managing deviations. Ability to understand complex scope, define qualification impact, and implement compliant execution strategies. Excellent communication skills and ability to lead independently in fast ‑ paced GMP environments. Thanks & Regards.
Kirti Singh VOTO Consulting LLC Phone:
Email: