Position Overview
We are seeking a Computer System Validation (CSV) Engineer that is able to join our pharmaceutical operations team Mid May 2026 .
Key Responsibilities - Manage the full CSV lifecycle (planning, design, testing, execution, reporting, and closure) for standalone systems such as LIMS, chromatography data systems, environmental monitoring software, and equipment control systems.
- Develop and execute validation documentation including User Requirement Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Perform risk assessments to determine validation scope and ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11 , and other relevant guidelines.
- Collaborate with QA, IT, and system owners to ensure proper change management, deviation handling, and system ...