CSL Behring
Associate Director, Human Factors Design and Development(m/w/x)
Full-timeOn-siteSenior
Bern
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CSCSL Behring
Senior Principal Engineer, Human Factors(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
Developing secondary packaging and Instructions for Use for biotherapeutics. Subject matter expertise in IEC 62366 standards required. Well-being support.
Requirements
- 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%
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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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CSCSL Behring
Senior Principal Engineer, Human Factors(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
Developing secondary packaging and Instructions for Use for biotherapeutics. Subject matter expertise in IEC 62366 standards required. Well-being support.
Requirements
- 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%
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Not a perfect match?
- CSL Behring
Associate Director, Human Factors Design and Development(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring
Senior Engineer (Drug Delivery Lead)(m/w/x)
Full-timeOn-siteManagementBern - CSL Behring
Senior Principal Engineer, Tech Ops(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring AG (CH)
Associate Director, Reliability and Product Improvement(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring
Head of Integrated Facility & Operations Services(m/w/x)
Full-timeOn-siteSeniorBern