Job Description:

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 21 CFR Part 11, 21 CFR Part 820, and GAMP 5 guidelines.


• Perform risk assessments to determine validation scope and testing requirements.