BioNTech SE
Engineer Compliance CSV & DI(m/w/x)
Full-timeOn-siteExperienced
Mainz
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Ensuring IT system compliance with global health authority regulations for a biotechnology firm. 5+ years pharmaceutical industry and regulated IT quality experience required. Flexible hours, vacation account, digital learning.
Requirements
- University degree in IT, Life Sciences, Pharmacy, Engineering or equivalent
- Minimum 3 years overall IT experience
- Minimum 5 years relevant pharmaceutical industry experience
- Minimum 5 years experience in regulated IT quality and compliance
- Solid understanding of global regulations and health authorities’ expectations
- Solid understanding of computerized systems regulations (CSV, Part 11, etc.)
- Solid experience in computerized systems development
- Solid experience in computerized systems implementation
- Solid experience in computerized systems lifecycle management
- Experience in regulated environments
- Experience in quality management of premises
- Experience in quality management of cloud-based regulated environments
- Highly experienced in operational management of GxP-solutions
- Highly experienced in GxP-solutions related technologies
- Good understanding in system application management
- Good understanding of system application quality support approach
- Good understanding of industry best practices (ITIL, ITSM, etc.)
- Experience in development of key computerized systems in pharma
- Experience in implementation of key computerized systems in pharma
- Experience in lifecycle management of key computerized systems in pharma
- Experience with ERP/SAP, MES, LIMS, CRM, IAM, etc.
- Strong analytical and problem-solving mindset
- Ability to think critically and strategically
- Proficient conflict management skills
- Ability to mediate and resolve stakeholder disagreements
- Excellent written communication skills
- Excellent verbal communication skills
- Ability for clear communication, content delivery, and stakeholder interaction
Tasks
- Lead compliance activities for IT systems
- Ensure alignment with regulatory and security requirements
- Manage compliance plans, reports, tests, changes, and reviews
- Handle deviations in compliance activities
- Serve as primary contact for CSV-related topics
- Liaise between technology teams and IT Compliance function
- Build strong partnerships with IT functions
- Provide day-to-day operational support
- Review and approve project documentation
- Determine GxP-applicability for systems
- Review and approve GxP-impacted deviations
- Ensure appropriate CAPA implementation
- Contribute to compliance strategy definition
- Execute system-level compliance plans
- Manage gaps within the CAPA Management System
- Support internal and external audits
- Offer compliance support for resulting CAPAs
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAP
- ERP
- MES
- LIMS
- CRM
- IAM
- ITIL
- ITSM
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 your 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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Ensuring IT system compliance with global health authority regulations for a biotechnology firm. 5+ years pharmaceutical industry and regulated IT quality experience required. Flexible hours, vacation account, digital learning.
Requirements
- University degree in IT, Life Sciences, Pharmacy, Engineering or equivalent
- Minimum 3 years overall IT experience
- Minimum 5 years relevant pharmaceutical industry experience
- Minimum 5 years experience in regulated IT quality and compliance
- Solid understanding of global regulations and health authorities’ expectations
- Solid understanding of computerized systems regulations (CSV, Part 11, etc.)
- Solid experience in computerized systems development
- Solid experience in computerized systems implementation
- Solid experience in computerized systems lifecycle management
- Experience in regulated environments
- Experience in quality management of premises
- Experience in quality management of cloud-based regulated environments
- Highly experienced in operational management of GxP-solutions
- Highly experienced in GxP-solutions related technologies
- Good understanding in system application management
- Good understanding of system application quality support approach
- Good understanding of industry best practices (ITIL, ITSM, etc.)
- Experience in development of key computerized systems in pharma
- Experience in implementation of key computerized systems in pharma
- Experience in lifecycle management of key computerized systems in pharma
- Experience with ERP/SAP, MES, LIMS, CRM, IAM, etc.
- Strong analytical and problem-solving mindset
- Ability to think critically and strategically
- Proficient conflict management skills
- Ability to mediate and resolve stakeholder disagreements
- Excellent written communication skills
- Excellent verbal communication skills
- Ability for clear communication, content delivery, and stakeholder interaction
Tasks
- Lead compliance activities for IT systems
- Ensure alignment with regulatory and security requirements
- Manage compliance plans, reports, tests, changes, and reviews
- Handle deviations in compliance activities
- Serve as primary contact for CSV-related topics
- Liaise between technology teams and IT Compliance function
- Build strong partnerships with IT functions
- Provide day-to-day operational support
- Review and approve project documentation
- Determine GxP-applicability for systems
- Review and approve GxP-impacted deviations
- Ensure appropriate CAPA implementation
- Contribute to compliance strategy definition
- Execute system-level compliance plans
- Manage gaps within the CAPA Management System
- Support internal and external audits
- Offer compliance support for resulting CAPAs
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAP
- ERP
- MES
- LIMS
- CRM
- IAM
- ITIL
- ITSM
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 your 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
- BioNTech SE
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