BioNTech SE
Engineer Compliance CSV & DI(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Mainz
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BIBioNTech SE
Engineer IT Compliance(m/w/x)
Mainz
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAP
- ERP
- MES
- LIMS
- CRM
- IAM
- ITIL
- ITSM
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital Learning
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Apprenticeships
- Support for your full potential
Startup-Atmosphäre
- Voice at the table
Lockere Unternehmenskultur
- Culture on an equal footing
Sinnstiftende Arbeit
- Opportunities to shape and impact
Firmenfahrrad
- Company bike
Öffi Tickets
- Job ticket
- Deutschlandticket
Betriebliche Altersvorsorge
- Employer-funded pension
Kinderbetreuung
- Childcare
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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BIBioNTech SE
Engineer IT Compliance(m/w/x)
Mainz
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAP
- ERP
- MES
- LIMS
- CRM
- IAM
- ITIL
- ITSM
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital Learning
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Apprenticeships
- Support for your full potential
Startup-Atmosphäre
- Voice at the table
Lockere Unternehmenskultur
- Culture on an equal footing
Sinnstiftende Arbeit
- Opportunities to shape and impact
Firmenfahrrad
- Company bike
Öffi Tickets
- Job ticket
- Deutschlandticket
Betriebliche Altersvorsorge
- Employer-funded pension
Kinderbetreuung
- Childcare
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
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- BioNTech SE
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