CSV Specialist Temporary Assignment (3 to 4 months)

Stellenbeschreibung:

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

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