Ensure continuous compliance of ERP applications with GxP, SOX and GDPR requirements
Act as CSV project lead: Responsible for the validation strategies and management of the computer systems in scope
Preparation and review of CSV documents in accordance with standard operating procedures, laws and guidelines
Continuous improvement of the compliance framework
Contribute to change management, deviation resolution and CAPAs, in close coordination with IT, QA, and business stakeholders
Act as an ERP compliance subject matter expert (SME) during internal audits, supplier audits, and health authority inspections

Relevant higher education and many years of professional experience (more than 5 years)
Proven track record of CSV and other compliance topics within regulated industries (e.g., pharma, chemical, medtech)
Extensive experience in GxP regulations
Well-organized with excellent documentation and analytical skills; able to synthesize complex information into clear, actionable insights
Ability to familiarize yourself with a variety of different (technical or regulatory) topics, with attention to detail and a quality-first mindset
Strong communication and stakeholder management skills, with the ability to interact confidently with business stakeholders, auditors, and cross-functional teams
Fluency in English. German knowledge is preferred

Senior Engineer, ERP Validation

Key skills