BioNTech SE
Specialist Manufacturing Processes Fill & Finish(m/w/x)
Vollzeit
Keine Angabe
Mainz
BI
BioNTech SE2 Monate
Process Engineer global MS&T(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
Mainz
Nejo KI-Zusammenfassung
In this role, you will focus on enhancing manufacturing processes for Fill & Finish, ensuring quality and compliance while collaborating with various teams. Your day-to-day responsibilities will include leading technology transfers, managing workflows, and driving continuous improvement initiatives.
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Anforderungen
- •University degree in Life Sciences, Engineering, or related field
- •3–5 years of experience in the life science industry, ideally in biotech or pharmaceutical manufacturing
- •Proven expertise in Fill & Finish process engineering and technology transfer
- •Strong knowledge of EU/US GMP guidelines and regulatory standards
- •Experience in GxP compliance consulting, risk analysis, and URS development
- •Strategic and analytical thinking with risk assessment skills
- •Excellent process management skills; Lean and Six Sigma qualifications preferred
- •Strong documentation and analytical skills, including statistical process monitoring
- •High team spirit and collaboration skills; ability to work cross-functionally
- •Fluency in German and English; additional languages are a plus
Bachelor-Abschluss
Berufserfahrung
3–5 Jahre
Deine Aufgaben
- •Adapt Fill & Finish manufacturing processes for efficient production
- •Optimize and implement manufacturing processes to ensure quality
- •Lead technology transfer activities and comparability assessments
- •Support process performance qualification efforts
- •Serve as the interface between internal stakeholders and manufacturing partners
- •Manage workflows and timelines for projects
- •Contribute to the implementation of process standards across products
- •Harmonize processes across different sites
- •Lead investigations and problem-solving for owned processes
- •Handle deviations and implement CAPA
- •Support the development and monitoring of KPIs
- •Implement process risk management strategies
- •Review and contribute to GMP documentation, including SOPs
- •Manage change controls and qualification protocols
- •Collaborate with cross-functional teams for process design alignment
- •Ensure regulatory compliance and operational execution
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Deine Vorteile
Flexibles Arbeiten
- •Flexible hours
Mehr Urlaubstage
- •Vacation account
Weiterbildungsangebote
- •Digital learning
- •Apprenticeships
- •LinkedIn Learning
Mentoring & Coaching
- •Performance & talent development
- •Leadership development
- •Support for your full potential
Startup-Atmosphäre
- •Your voice at the table
Lockere Unternehmenskultur
- •Culture on an equal footing
Sinnstiftende Arbeit
- •Opportunities to shape & 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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