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CSV Lead

Company

Katalyst Healthcares &amp; Life Sciences

Location

South Plainfield, New Jersey, United States

Posted

May 16, 2026

Position Overview

                 Roles and Responsibilities:  

   Lead end-to-end Computer System Validation for GxP systems.  

   Develop and review URS, risk assessments, IQ/OQ/PQ protocols, and validation reports.  

   Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GxP.  

   Manage validation risk and maintain systems in a validated state.  

   Collaborate with IT, QA, Labs, and vendors.

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CSV Lead

Position Overview

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