Computer System Validation Specialist | Spezialist Computervalidierung/Informatiker (m/w/d)

Job Summary

This role involves planning, coordinating, and executing validation projects for complex computerized systems within the highly regulated Pharmaceutical and Life Science industries. The specialist will be responsible for creating, reviewing, and maintaining comprehensive validation documentation, including risk analyses, validation plans, test protocols, and final reports. A core function is ensuring strict adherence to critical regulatory requirements such as GxP, EU-GMP Annex 11, and 21 CFR Part 11. Day-to-day tasks include managing system introductions, upgrades, and changes through formal Change Control processes, conducting various tests (Functional, Integration, Regression), and providing expert advice to IT and Business units on system validation, data integrity, and compliance matters. This position offers the opportunity to work with a specialized engineering service provider focused on quality and sustainable solutions, featuring flexible working models and a supportive team environment.