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

Job Summary

This role is ideal for a detail-oriented (Junior) Computer System Validation (CSV) Specialist looking to drive critical qualification projects within the pharmaceutical and life science sectors. Day-to-day responsibilities involve executing CSV and qualification projects for complex systems such as MES, LIMS, PLS, and automated production facilities. A core function is creating essential system life cycle documentation, including Validation Plans, Requirement Specifications, Risk Analyses, and Test Plans, while actively conducting qualification measures (DQ, IQ, OQ, PQ). The specialist will perform GAP analyses against stringent pharmaceutical quality standards, advise clients on implementing robust IT validation concepts, and support crucial GMP-specific audits, IT Change Management, and Test Management activities. Key requirements include a completed technical degree or training combined with professional experience in qualification/validation in the pharma industry, coupled with solid knowledge of current European and American GMP regulations, including Annex 11, 21 CFR Part 11, and ISPE GAMP 5. This position offers diverse projects and significant professional development opportunities.