F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Full-timeOn-siteSenior
Basel
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Leading primary packaging integration for drug delivery devices, focusing on prefilled syringes and cartridge-based container closure systems. 10+ years in parenteral manufacturing or related fields required. Personal expression encouraged, open dialogue.
Requirements
- Strong leadership and communication skills
- Successful establishment and management of cross-functional teams
- M.Sc. or Diploma degree (and 10+ years) or PhD degree (and 6+ years)
- Degree in Parenteral manufacturing, Parenteral process development, Container closure and combination product development, Product Quality, Analytical, Material Sciences, or related fields
- Experience in pharma/biotech/medical device industry
- Expert knowledge in container closure systems
- Practical experience in container closure systems
- Profound knowledge in Aseptic processing
- Profound knowledge in CCS materials
- Profound knowledge in E&L concepts
- Profound knowledge in functional CCS characterization
- Profound knowledge in Container Closure Integrity testing
- Profound knowledge of quality requirements for container closure systems
- Profound knowledge of regulatory requirements for container closure systems
- Profound knowledge of quality requirements for parenteral pharmaceutical products
- Profound knowledge of regulatory requirements for parenteral pharmaceutical products
- Profound knowledge of quality requirements for biopharmaceutical products
- Profound knowledge of regulatory requirements for biopharmaceutical products
- Profound knowledge of quality requirements for primary packaging materials
- Profound knowledge of regulatory requirements for primary packaging materials
- Profound knowledge of quality requirements for drug/device combinations products
- Profound knowledge of regulatory requirements for drug/device combinations products
- Practical experience in Parenteral Fill finish processes
- Strong knowledge of Parenteral Fill finish processes
- Solid understanding of pharmaceutical development in cGMP environment
Tasks
- Lead primary packaging integration for drug delivery devices
- Serve as technical lead for prefilled syringes (PFS)
- Serve as technical lead for cartridge-based container closure systems (CCS)
- Ensure seamless integration with autoinjectors
- Ensure seamless integration with needle safety systems
- Bridge formulation requirements and device performance
- Deliver safe, effective, patient-centric injectable products
- Provide CCS technical expertise and guidance
- Collaborate with global multi-functional teams
- Support early development through product launch
- Provide technical commercial support
- Manage product life cycle
- Cooperate with Technical Development Teams
- Interact with Regulatory
- Interact with Manufacturing Science & Technology (MSAT)
- Interact with Operations
- Interact with CMOs
- Interact with Quality
- Interact with Suppliers
- Interact with other stakeholders
- Partner with platform device teams
- Develop system-level requirements for combination products
- Verify system-level requirements
- Validate system-level requirements
- Align with design control
- Support continuity of supply for marketed products
- Ensure technical performance of primary packaging
- Ensure processability of primary packaging
- Ensure safety of primary packaging
- Lead CCS technical impact assessment for investigations
- Lead CCS technical impact assessment for complaints
- Lead CCS technical impact assessment for change control
- Contribute to safety assessments of component materials
- Contribute to safety assessments of container closure systems
- Provide technical expertise for troubleshooting
- Troubleshoot primary packaging issues
- Troubleshoot component defects
- Troubleshoot drug product manufacturing processes
- Troubleshoot inspection issues
Work Experience
- approx. 4 - 6 years
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- cGMP
Benefits
Informal Culture
- Personal expression encouraged
- Open dialogue
- Genuine connections
- Valued, accepted, and respected
Mentorship & Coaching
- Personal and professional thriving
Healthcare & Fitness
- Prevent, stop, and cure diseases
- Healthcare access
- Life-changing healthcare solutions
Startup Environment
- Innovation driven
Other Benefits
- Science advancement
Social Impact
- Global impact
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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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Leading primary packaging integration for drug delivery devices, focusing on prefilled syringes and cartridge-based container closure systems. 10+ years in parenteral manufacturing or related fields required. Personal expression encouraged, open dialogue.
Requirements
- Strong leadership and communication skills
- Successful establishment and management of cross-functional teams
- M.Sc. or Diploma degree (and 10+ years) or PhD degree (and 6+ years)
- Degree in Parenteral manufacturing, Parenteral process development, Container closure and combination product development, Product Quality, Analytical, Material Sciences, or related fields
- Experience in pharma/biotech/medical device industry
- Expert knowledge in container closure systems
- Practical experience in container closure systems
- Profound knowledge in Aseptic processing
- Profound knowledge in CCS materials
- Profound knowledge in E&L concepts
- Profound knowledge in functional CCS characterization
- Profound knowledge in Container Closure Integrity testing
- Profound knowledge of quality requirements for container closure systems
- Profound knowledge of regulatory requirements for container closure systems
- Profound knowledge of quality requirements for parenteral pharmaceutical products
- Profound knowledge of regulatory requirements for parenteral pharmaceutical products
- Profound knowledge of quality requirements for biopharmaceutical products
- Profound knowledge of regulatory requirements for biopharmaceutical products
- Profound knowledge of quality requirements for primary packaging materials
- Profound knowledge of regulatory requirements for primary packaging materials
- Profound knowledge of quality requirements for drug/device combinations products
- Profound knowledge of regulatory requirements for drug/device combinations products
- Practical experience in Parenteral Fill finish processes
- Strong knowledge of Parenteral Fill finish processes
- Solid understanding of pharmaceutical development in cGMP environment
Tasks
- Lead primary packaging integration for drug delivery devices
- Serve as technical lead for prefilled syringes (PFS)
- Serve as technical lead for cartridge-based container closure systems (CCS)
- Ensure seamless integration with autoinjectors
- Ensure seamless integration with needle safety systems
- Bridge formulation requirements and device performance
- Deliver safe, effective, patient-centric injectable products
- Provide CCS technical expertise and guidance
- Collaborate with global multi-functional teams
- Support early development through product launch
- Provide technical commercial support
- Manage product life cycle
- Cooperate with Technical Development Teams
- Interact with Regulatory
- Interact with Manufacturing Science & Technology (MSAT)
- Interact with Operations
- Interact with CMOs
- Interact with Quality
- Interact with Suppliers
- Interact with other stakeholders
- Partner with platform device teams
- Develop system-level requirements for combination products
- Verify system-level requirements
- Validate system-level requirements
- Align with design control
- Support continuity of supply for marketed products
- Ensure technical performance of primary packaging
- Ensure processability of primary packaging
- Ensure safety of primary packaging
- Lead CCS technical impact assessment for investigations
- Lead CCS technical impact assessment for complaints
- Lead CCS technical impact assessment for change control
- Contribute to safety assessments of component materials
- Contribute to safety assessments of container closure systems
- Provide technical expertise for troubleshooting
- Troubleshoot primary packaging issues
- Troubleshoot component defects
- Troubleshoot drug product manufacturing processes
- Troubleshoot inspection issues
Work Experience
- approx. 4 - 6 years
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- cGMP
Benefits
Informal Culture
- Personal expression encouraged
- Open dialogue
- Genuine connections
- Valued, accepted, and respected
Mentorship & Coaching
- Personal and professional thriving
Healthcare & Fitness
- Prevent, stop, and cure diseases
- Healthcare access
- Life-changing healthcare solutions
Startup Environment
- Innovation driven
Other Benefits
- Science advancement
Social Impact
- Global impact
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Not a perfect match?
- F. Hoffmann-La Roche AG
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