Senior Engineer ERP Validation

Senior Engineer Erp Validation

Mainz, Germany | full time | Job ID: 9322

The Project Lead CSV for ERP Applications is responsible for ensuring that all ERP systems in scope operate in compliance with relevant regulatory frameworks, including GXP (Good Practice), FDA 21 CFR Part 11, EU GMP Annex 11, and Sarbanes-Oxley (SOX) Section 404. The position acts as CSV project lead and thus plays a critical role in maintaining the validated state of ERP applications. It extends to all other relevant compliance activities, such as compliance framework development/update, Deviation- and CAPA management, change control and periodic review support. Your responsibilities are:

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

What you have to offer:

• 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.

Your benefits:

• 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

Apply now - We look forward to your application!

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 12 PM to 4 PM CET).

Job ID 9322 (please always specify if you have any questions)

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.

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