Senior Engineer ERP Validation

Mainz, Germany | full time | Job ID:10597

Responsibilities

• 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

Qualifications

• 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

Benefits

• Your flexibility: flexible hours | vacation account
• 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 life phases: Employer‑funded pension | Childcare

Apply

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131‑9084‑1291 (Monday‑Friday from 1 PM to 3 PM CET).

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech‑Recruiter.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer.