CSL Behring
Senior Principal Engineer, Tech Ops(m/w/x)
Vollzeitnur vor OrtSenior
Bern
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CSCSL Behring AG (CH)
Associate Director, Reliability and Product Improvement(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Technical leadership for marketed combination products in biotherapeutics. 10+ years in parenteral or device manufacturing required. Well-being support, team management experience.
Anforderungen
- Bachelor's in engineering (mechanical or chemical preferred)
- Minimum 10 years of experience in parenteral or device manufacturing in pharmaceutical space
- Leadership experience in team management or supervision
- Experience with manufacturing processes, validation practices, and cGMP guidelines
- Knowledge of process automation and equipment reliability
- Ability to collaborate with internal teams, CMs, and contractors
Aufgaben
- Provide technical leadership for marketed combination products
- Collaborate with DDSP and Quality Assurance for product improvements
- Implement process optimization and CDMO evaluation
- Manage tech transfers and supplier-related changes
- Update risk management practices
- Identify and standardize best practices for combination products
- Interface with project teams and external organizations
- Scope and vet design improvement projects
- Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 4, QMSR, and 211
- Follow relevant ICH guidelines
- Partner with manufacturing, CDMOs, and quality for design improvements
- Drive process optimizations and supplier changes through change control
- Represent the function in cross-functional program teams
- Participate in design reviews and regulatory interactions
- Provide expert input on device reliability for Health Authority submissions
- Support regulatory audits and inspections
- Maintain knowledge of evolving combination product regulations
- Monitor and improve the product complaint process
- Educate new product development leads on best practices
- Utilize technical project management skills
- Plan resources and work
- Manage risks and prioritize tasks
- Resolve conflicts and manage changes
- Report project progress
- Ensure safety, quality, and reliability of commercialized products
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mentale Gesundheitsförderung
- Well-being support
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring AG (CH) 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.
Noch nicht perfekt?
- CSL Behring
Associate Director, Quality Assurance Support(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Senior Engineer (Drug Delivery Lead)(m/w/x)
Vollzeitnur vor OrtManagementBern - CSL Behring
Associate Director, Human Factors Design and Development(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern
CSCSL Behring AG (CH)
Associate Director, Reliability and Product Improvement(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Technical leadership for marketed combination products in biotherapeutics. 10+ years in parenteral or device manufacturing required. Well-being support, team management experience.
Anforderungen
- Bachelor's in engineering (mechanical or chemical preferred)
- Minimum 10 years of experience in parenteral or device manufacturing in pharmaceutical space
- Leadership experience in team management or supervision
- Experience with manufacturing processes, validation practices, and cGMP guidelines
- Knowledge of process automation and equipment reliability
- Ability to collaborate with internal teams, CMs, and contractors
Aufgaben
- Provide technical leadership for marketed combination products
- Collaborate with DDSP and Quality Assurance for product improvements
- Implement process optimization and CDMO evaluation
- Manage tech transfers and supplier-related changes
- Update risk management practices
- Identify and standardize best practices for combination products
- Interface with project teams and external organizations
- Scope and vet design improvement projects
- Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 4, QMSR, and 211
- Follow relevant ICH guidelines
- Partner with manufacturing, CDMOs, and quality for design improvements
- Drive process optimizations and supplier changes through change control
- Represent the function in cross-functional program teams
- Participate in design reviews and regulatory interactions
- Provide expert input on device reliability for Health Authority submissions
- Support regulatory audits and inspections
- Maintain knowledge of evolving combination product regulations
- Monitor and improve the product complaint process
- Educate new product development leads on best practices
- Utilize technical project management skills
- Plan resources and work
- Manage risks and prioritize tasks
- Resolve conflicts and manage changes
- Report project progress
- Ensure safety, quality, and reliability of commercialized products
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mentale Gesundheitsförderung
- Well-being support
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring AG (CH) 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.
Über das Unternehmen
CSL Behring AG (CH)
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein weltweit führendes Biotech-Unternehmen, das lebensrettende Therapien für Menschen mit schweren und seltenen Krankheiten entwickelt und vertreibt.
Noch nicht perfekt?
- CSL Behring
Senior Principal Engineer, Tech Ops(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Associate Director, Quality Assurance Support(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Senior Engineer (Drug Delivery Lead)(m/w/x)
Vollzeitnur vor OrtManagementBern - CSL Behring
Associate Director, Human Factors Design and Development(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern