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BI
BioNTech SE
last mo.

Senior Engineer ERP Validation(m/w/x)

Mainz
Full-timeOn-siteSenior

Description

In this role, you will ensure ERP applications meet compliance standards while leading validation projects. Your day-to-day responsibilities will involve preparing documentation, improving compliance frameworks, and collaborating with various stakeholders during audits and inspections.

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Requirements

  • Relevant higher education and more than 5 years of professional experience
  • Proven track record of CSV and compliance topics in regulated industries
  • Extensive experience in GxP regulations
  • Well-organized with excellent documentation and analytical skills
  • Attention to detail and quality-first mindset
  • Strong communication and stakeholder management skills
  • Fluency in English; German knowledge preferred

Education

Bachelor's degree

Work Experience

5 years

Tasks

  • Ensure continuous compliance of ERP applications with GxP, SOX, and GDPR requirements
  • Act as CSV project lead for validation strategies and management of computer systems
  • Prepare and review CSV documents according to standard operating procedures and regulations
  • Improve the compliance framework continuously
  • Contribute to change management and deviation resolution
  • Manage CAPAs in coordination with IT, QA, and business stakeholders
  • Serve as ERP compliance subject matter expert during audits and inspections

Languages

EnglishBusiness Fluent

GermanBasic

Benefits

Flexible Working

  • Flexible hours

More Vacation Days

  • Vacation account

Learning & Development

  • Digital learning
  • Apprenticeships
  • LinkedIn learning

Career Advancement

  • Performance and talent development
  • Leadership development

Other Benefits

  • Your voice at the table
  • Support for your full potential

Informal Culture

  • Culture on an equal footing

Purpose-Driven Work

  • Opportunities to shape and impact

Company Bike

  • Company bike

Public Transport Subsidies

  • Job ticket
  • Deutschlandticket

Retirement Plans

  • Employer-funded pension

Childcare

  • Childcare
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