Position Overview
Job Summary:
We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE. In this role, you will be responsible for ensuring that computerised systems used in regulated environments are validated and compliant with industry standards. You will work closely with IT, Quality, and business teams to support validation activities and maintain system compliance throughout its lifecycle. Roles & Responsibilities: Lead and support CSV activities for GxP systems, including validation planning, execution, and reporting Develop and review validation deliverables such as Validation Plans, URS, FS/DS, IQ, OQ, PQ protocols, and summary reports Ensure compliance with FDA CFR Part , CFR Part , and GAMP guidelines Perform risk assessments to determine validation scope and testing requirements Support system implementation, upgrades, and changes through change control processes ...