We are looking for a structured and detail oriented CSV Specialist to support regulated operations within a temporary project assignment in Marburg, Germany. In this role, you ensure that computerized systems are validated according to regulatory requirements and internal quality standards. You play a key role in safeguarding data integrity, compliance and operational excellence across IT and business systems. Key Responsibilities • Plan, execute and document Computer System Validation activities according to GxP and relevant guidelines • Create and maintain validation documents such as URS, FRS, risk assessments, test plans, test cases and validation reports • Review and approve system changes, ensuring continued validated status • Support audits and inspections by preparing documentation and providing expert input • Collaborate with IT, Quality Assurance and business stakeholders on system implementations and improvements • Ensure compliance with applicable regulations such as GAMP 5, FDA 21 CFR Part 11 and EU Annex 11 • Maintain CSV documentation in line with internal procedures and quality standards Requirements Your Profile • Degree in Life Sciences, Computer Science, Engineering or a related field • Experience in Computer System Validation within regulated environments such as pharma, biotech, medtech or healthcare • Solid understanding of GxP, data integrity principles and regulatory frameworks • Experience with validation of systems such as ERP, LIMS, QMS, MES or similar • Strong analytical mindset with high attention to detail • Structured working style and strong documentation skills • Fluent in English, German is a strong advantage Assignment Details • On-site assignment in Marburg, Germany • Temporary project duration of 3 to 4 months • Immediate availability preferred