CSV Specialist bei Avacone

Description

We are looking for a structured and detail oriented CSV Specialist to support our regulated operations. 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