CSL Behring
Senior Principal Engineer, Tech Ops(m/w/x)
Full-timeOn-siteSenior
Bern
New Job?Nejo!
Your personal AI career agent
CSCSL Behring AG (CH)
Associate Director, Reliability and Product Improvement(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
Technical leadership for marketed combination products in biotherapeutics. 10+ years in parenteral or device manufacturing required. Well-being support, team management experience.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 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 AG (CH) 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.
Not a perfect match?
- CSL Behring
Associate Director, Quality Assurance Support(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring
Senior Engineer (Drug Delivery Lead)(m/w/x)
Full-timeOn-siteManagementBern - CSL Behring
Associate Director, Human Factors Design and Development(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring
Head of Integrated Facility & Operations Services(m/w/x)
Full-timeOn-siteSeniorBern
CSCSL Behring AG (CH)
Associate Director, Reliability and Product Improvement(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
Technical leadership for marketed combination products in biotherapeutics. 10+ years in parenteral or device manufacturing required. Well-being support, team management experience.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 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 AG (CH) 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 AG (CH)
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein weltweit führendes Biotech-Unternehmen, das lebensrettende Therapien für Menschen mit schweren und seltenen Krankheiten entwickelt und vertreibt.
Not a perfect match?
- CSL Behring
Senior Principal Engineer, Tech Ops(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring
Associate Director, Quality Assurance Support(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring
Senior Engineer (Drug Delivery Lead)(m/w/x)
Full-timeOn-siteManagementBern - CSL Behring
Associate Director, Human Factors Design and Development(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring
Head of Integrated Facility & Operations Services(m/w/x)
Full-timeOn-siteSeniorBern