| Sr CQV Specialist at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3419142&uid=4a4f9e8dbbbf4367a2adb4f995b78382 From: Prince Roy, vyze.inc [email protected] Reply to: [email protected] Sr CQV Specialist Location: Raritan New Jersey 100% on site Card or US only MOI: Virtual Interviews Contract Length: 2+ Years LinkedIn, Visa and Dl copy Job Description: 8+ years experience Process equipment, QC equipment, facilities validation, smoke studies Able to write validation plans and execute Work on multiple projects and hit the ground running 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. Responsibilities Lead and own CQV activities across facility, QC, process, and computerized systems, including cleanrooms, smoke studies, and qualified equipment. Develop and execute robust, risk-based qualification strategies grounded in USP <1058>, GAMP 5, and system impact assessments (ISP guidelines). Author and execute validation plans, protocols, reports, risk assessments, and GxP documentation. Drive execution activities, proactively resolving issues, deviations, and remediation items during qualification. Lead deviation investigations, impact assessments, and corrective actions. Support qualification of cell therapyspecific and QC systems such as qPCR, BacT, Faxitron, and microplate readers. Quickly onboard to new projects and scopes, independently managing execution from planning through approval. Represent CQV activities during internal and regulatory inspections as needed. 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. Keywords: information technology Sr CQV Specialist [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3419142&uid=4a4f9e8dbbbf4367a2adb4f995b78382 |
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| 04:38 AM 03-Jun-26 |