# CSV Specialist Temporary Assignment (3 to 4 months)

> Avacone · Marburg, Germany · Temporary · Posted 2026-04-22

**Workplace:** on_site

**Department:** Germany

## Description

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

## Apply

[Apply at Avacone](https://apply.workable.com/avacone/j/E78D5C4667/apply)

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