Information Technology Specialist (GxP Systems) | Informationstechnologe (m/w/d)

Job Summary

This role involves acting as a technical business partner within a biotechnology company specializing in vaccine production, focusing on the implementation, operation, and administration of GxP-relevant systems within the laboratory environment. The specialist will ensure regulatory compliance by managing GxP applications like LIMS and Environmental Monitoring systems, and instrument-related software. Key responsibilities include serving as the System Owner for GxP lab applications, managing vendor interfaces, and contributing to Computer System Validation (CSV) projects according to regulatory standards (e.g., GAMP 5, 21 CFR Part 11). The ideal candidate must possess strong analytical and troubleshooting skills, be proficient in both German and English, and have extensive experience managing GxP documentation (SOPs, URS) and handling Deviation, CAPA, and Change Control processes. This position is crucial for maintaining stable, compliant operations in a highly regulated biotech setting.