BioNTech SE
Engineer Compliance CSV & DI(m/w/x)
Full-timeOn-siteExperienced
Mainz
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Leading CSV projects and GxP documentation for ERP applications in medicine development. Extensive GxP regulations experience and CSV track record required. Flexible hours, vacation account.
Requirements
- Relevant higher education
- More than 5 years professional experience
- Track record of CSV and compliance
- Extensive experience in GxP regulations
- Excellent documentation and analytical skills
- Attention to detail and quality-first mindset
- Strong communication and stakeholder management skills
- Fluency in English
- German knowledge preferred
Tasks
- Ensure ERP applications comply with GxP, SOX, and GDPR
- Lead CSV projects and define validation strategies
- Prepare and review CSV documentation following legal guidelines
- Improve the company's compliance framework continuously
- Manage change control, deviations, and CAPA resolutions
- Coordinate closely with IT, QA, and business stakeholders
- Serve as an ERP compliance expert during audits and inspections
- Maintain the validated state of all ERP systems
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- CSV
- GxP
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital Learning
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for full potential
Startup Environment
- Voice at the table
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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Leading CSV projects and GxP documentation for ERP applications in medicine development. Extensive GxP regulations experience and CSV track record required. Flexible hours, vacation account.
Requirements
- Relevant higher education
- More than 5 years professional experience
- Track record of CSV and compliance
- Extensive experience in GxP regulations
- Excellent documentation and analytical skills
- Attention to detail and quality-first mindset
- Strong communication and stakeholder management skills
- Fluency in English
- German knowledge preferred
Tasks
- Ensure ERP applications comply with GxP, SOX, and GDPR
- Lead CSV projects and define validation strategies
- Prepare and review CSV documentation following legal guidelines
- Improve the company's compliance framework continuously
- Manage change control, deviations, and CAPA resolutions
- Coordinate closely with IT, QA, and business stakeholders
- Serve as an ERP compliance expert during audits and inspections
- Maintain the validated state of all ERP systems
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- CSV
- GxP
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital Learning
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for full potential
Startup Environment
- Voice at the table
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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
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