Job Description
Position Overview
We are seeking a Computer System Validation (CSV) Engineer that is able to join our pharmaceutical operations team Mid May 2026 . The successful candidate will be responsible for ensuring compliance of computerized systems with regulatory requirements, focusing on the qualification of standalone systems used in GMP manufacturing and laboratory environments.
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). ...