CSV Specialist Temporary Assignment (3 to 4 months) chez Avacone

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