CSL Behring
Associate Director, Human Factors Design and Development(m/w/x)
Vollzeitnur vor OrtSenior
Bern
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CSCSL Behring
Senior Principal Engineer, Human Factors(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing secondary packaging and Instructions for Use for biotherapeutics. Subject matter expertise in IEC 62366 standards required. Well-being support.
Anforderungen
- Excellent communication skills
- Track record working in matrix environment
- Ability to influence and promote continuous improvement
- Subject matter expertise in IEC 62366 standards
- Subject matter expertise in related regulatory guidance
- Understanding of user capabilities – anthropometric basis
- Proficiency in using risk assessments
- Proven track record evaluating user interfaces for drug delivery devices
- Proven track record developing instructional materials for product labelling and artwork
- Relevant academic qualification in Ergonomics, Psychology, or Science/Engineering degree
- At least 8 years related experience in pharmaceutical or medical device industry
- Ability to travel internationally up to 20%
Aufgaben
- Lead Human Factors Engineering activities
- Plan and execute HFE activities in drug delivery projects
- Develop secondary packaging and Instructions for Use
- Set and drive best practices for HFE in DDS&P
- Support standardization of Task Analysis and Use Risk Assessment
- Lead HF oversight of secondary packaging development
- Partner with project leads and cross-functional teams
- Develop selection criteria for user interfaces
- Evaluate user interfaces for new products
- Collect and maintain data on user capabilities and use problems
- Contribute to Company Core Data Sheets development
- Plan and execute Formative and Summative evaluations
- Select and oversee CROs for evaluations
- Leverage existing data for regulatory submissions
- Develop HF content for dossier submissions
- Respond to regulatory agency questions
- Monitor industry trends, standards, and regulatory guidance
Berufserfahrung
- 8 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 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
Senior Engineer (Drug Delivery Lead)(m/w/x)
Vollzeitnur vor OrtManagementBern - CSL Behring
Senior Principal Engineer, Tech Ops(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Senior Production Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern
CSCSL Behring
Senior Principal Engineer, Human Factors(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing secondary packaging and Instructions for Use for biotherapeutics. Subject matter expertise in IEC 62366 standards required. Well-being support.
Anforderungen
- Excellent communication skills
- Track record working in matrix environment
- Ability to influence and promote continuous improvement
- Subject matter expertise in IEC 62366 standards
- Subject matter expertise in related regulatory guidance
- Understanding of user capabilities – anthropometric basis
- Proficiency in using risk assessments
- Proven track record evaluating user interfaces for drug delivery devices
- Proven track record developing instructional materials for product labelling and artwork
- Relevant academic qualification in Ergonomics, Psychology, or Science/Engineering degree
- At least 8 years related experience in pharmaceutical or medical device industry
- Ability to travel internationally up to 20%
Aufgaben
- Lead Human Factors Engineering activities
- Plan and execute HFE activities in drug delivery projects
- Develop secondary packaging and Instructions for Use
- Set and drive best practices for HFE in DDS&P
- Support standardization of Task Analysis and Use Risk Assessment
- Lead HF oversight of secondary packaging development
- Partner with project leads and cross-functional teams
- Develop selection criteria for user interfaces
- Evaluate user interfaces for new products
- Collect and maintain data on user capabilities and use problems
- Contribute to Company Core Data Sheets development
- Plan and execute Formative and Summative evaluations
- Select and oversee CROs for evaluations
- Leverage existing data for regulatory submissions
- Develop HF content for dossier submissions
- Respond to regulatory agency questions
- Monitor industry trends, standards, and regulatory guidance
Berufserfahrung
- 8 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 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
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Noch nicht perfekt?
- CSL Behring
Associate Director, Human Factors Design and Development(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Senior Engineer (Drug Delivery Lead)(m/w/x)
Vollzeitnur vor OrtManagementBern - CSL Behring
Senior Principal Engineer, Tech Ops(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Senior Production Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern