(Junior) Computer System Validation Specialist (Pharma) | (Junior) CSV Specialist Pharma (m/w/d)

Job Summary

This role is designed for an ambitious (Junior) Computer System Validation (CSV) Specialist eager to drive technology forward within the pharmaceutical and life science sectors. Day-to-day tasks involve executing critical CSV and qualification projects for systems such as MES, LIMS, PLS, and automated production facilities. A core function is the creation of comprehensive system life-cycle documentation, including Validation and Qualification Plans, Requirement Specifications, Risk Analyses, and Test Plans. You will be responsible for guiding and executing qualification measures (DQ, IQ, OQ, PQ), performing GAP analyses against stringent pharmaceutical quality standards, and advising clients on implementing robust IT validation concepts. Success requires foundational expertise in CSV, validation, and strict adherence to current European and American GMP regulations, specifically Annex 11, 21 CFR Part 11, and ISPE GAMP 5. This position offers an unlimited contract, diverse advanced training opportunities, and the chance to actively contribute innovative ideas to challenging projects.