Senior Engineer ERP Validation
Mainz, Germany | full time | Job ID:9322
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.
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare