CSV Engineer Pharma | CSV Engineer (m/w/d) Pharma

Job Summary

This critical role involves ensuring the validated state of all GxP-relevant computerized systems across production, engineering, and logistics, strictly adhering to GMP regulations within a pharmaceutical manufacturing environment. The CSV Engineer will manage the validation of new and existing computerized systems, including serving as a sub-project leader for computer system-relevant topics in larger projects. Key responsibilities include creating and reviewing validation documentation and standard operating procedures (SOPs) for Computer System Validation (CSV), conducting risk analyses, and managing change control. Candidates must possess a degree in Computer Science or a related technical field, coupled with several years of practical experience in CSV, ideally within the chemical or other regulated industries, and strong familiarity with GAMP®5 guidelines. This position offers an opportunity to contribute to global health access within a stable, growing Viatris company (Madaus GmbH) near Cologne/Bonn.