IT Compliance and Validation Specialist | Informatiker (m/w/d)

Job Summary

This role is centered on ensuring IT systems, applications, and infrastructure comply with stringent regulatory standards within a highly regulated environment, such as the Pharmaceutical Industry or Medical Devices sector. The specialist will serve as a key consultant, guiding ZEISS segments through the validation process for new system introductions and changes. Core responsibilities include developing, maintaining, and continuously improving the IT Compliance Framework, encompassing policies, processes, and tooling. You will actively integrate validation requirements into projects, monitor their execution, and ensure adherence to GxP standards (e.g., 21 CFR Part 11, EU GMP Annex 11, GAMP5). Furthermore, the role involves training internal operations teams to sustain the validated status of systems and optimizing validation procedures for greater efficiency and compliance. Success requires a strong background in Computer Science or Engineering and proven experience in computer system validation within regulated fields.