What are the responsibilities and job description for the Validation Engineer position at Voto Consulting LLC?
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:
Salary : $55