F. Hoffmann-La Roche AG
Senior Technical Sub-Project Manager Packaging & Assembly(m/w/x)
Full-timeOn-siteSenior
Kaiseraugst
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RORoche
Device Technology Deployment Manager(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Deploying and industrializing new medical device equipment and packaging technologies. 7+ years technical project management experience in regulated environments required. Company car for private use, 6 weeks vacation.
Requirements
- Bachelor's or Master's degree in Engineering, Science, or related technical field
- 7+ years technical Project Management experience (CAPEX-projects)
- Experience deploying, industrializing, and qualifying new equipment/technologies
- Expertise in supplier management, URS, machine risk assessments, C&Q strategies
- Experience in highly regulated environment (Medical Device/Pharmaceutical)
- Solid understanding of cGMP, ISO standards, FDA regulations
- Deep knowledge of medical device manufacturing processes
- Hands-on experience in Device Assembly, Final Sterilization, or Final Packaging
- Lead and support process development and technology scaling
- Familiarity with Automation/MES systems (advantageous)
- Exceptional communication, negotiation, and influencing skills
- Fluent in English
- Willingness to travel internationally (up to 25%)
- PMP or other recognized certification (highly desirable)
Tasks
- Lead end-to-end device and packaging technology deployment projects
- Execute end-to-end device and packaging technology deployment projects
- Drive strategic equipment initiatives
- Drive strategic process initiatives
- Enhance product robustness
- Enhance product efficiency
- Enhance product future-readiness
- Introduce novel technologies across the product lifecycle
- Own the technology lifecycle from concept assessment
- Own the technology lifecycle through pilot execution
- Own the technology lifecycle through large-scale deployment
- Evaluate feasibility
- Evaluate scalability
- Evaluate implementation readiness
- Proactively identify risks
- Implement effective mitigation strategies
- Oversee critical equipment acceptance protocols
- Execute critical equipment acceptance protocols
- Coordinate user engagement for acceptance protocols
- Ensure compliance with regulated standards
- Ensure timely review of design deliverables
- Ensure timely approval of design deliverables
- Ensure timely review of qualification deliverables
- Ensure timely approval of qualification deliverables
- Ensure timely review of validation deliverables
- Ensure timely approval of validation deliverables
- Partner with Site Engineering on deliverables
- Partner with Quality on deliverables
- Partner with Device Development on deliverables
- Partner with MSAT on deliverables
- Partner with User teams on deliverables
- Ensure seamless cross-functional coordination
- Ensure alignment among key project stakeholders
- Manage the full supplier relationship lifecycle
- Select suppliers
- Engage suppliers via contract
- Monitor supplier performance
- Review critical technical documentation from suppliers
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Automation/MES systems
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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Senior Device Engineer(m/w/x)
Full-timeOn-siteManagementBasel
RORoche
Device Technology Deployment Manager(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Deploying and industrializing new medical device equipment and packaging technologies. 7+ years technical project management experience in regulated environments required. Company car for private use, 6 weeks vacation.
Requirements
- Bachelor's or Master's degree in Engineering, Science, or related technical field
- 7+ years technical Project Management experience (CAPEX-projects)
- Experience deploying, industrializing, and qualifying new equipment/technologies
- Expertise in supplier management, URS, machine risk assessments, C&Q strategies
- Experience in highly regulated environment (Medical Device/Pharmaceutical)
- Solid understanding of cGMP, ISO standards, FDA regulations
- Deep knowledge of medical device manufacturing processes
- Hands-on experience in Device Assembly, Final Sterilization, or Final Packaging
- Lead and support process development and technology scaling
- Familiarity with Automation/MES systems (advantageous)
- Exceptional communication, negotiation, and influencing skills
- Fluent in English
- Willingness to travel internationally (up to 25%)
- PMP or other recognized certification (highly desirable)
Tasks
- Lead end-to-end device and packaging technology deployment projects
- Execute end-to-end device and packaging technology deployment projects
- Drive strategic equipment initiatives
- Drive strategic process initiatives
- Enhance product robustness
- Enhance product efficiency
- Enhance product future-readiness
- Introduce novel technologies across the product lifecycle
- Own the technology lifecycle from concept assessment
- Own the technology lifecycle through pilot execution
- Own the technology lifecycle through large-scale deployment
- Evaluate feasibility
- Evaluate scalability
- Evaluate implementation readiness
- Proactively identify risks
- Implement effective mitigation strategies
- Oversee critical equipment acceptance protocols
- Execute critical equipment acceptance protocols
- Coordinate user engagement for acceptance protocols
- Ensure compliance with regulated standards
- Ensure timely review of design deliverables
- Ensure timely approval of design deliverables
- Ensure timely review of qualification deliverables
- Ensure timely approval of qualification deliverables
- Ensure timely review of validation deliverables
- Ensure timely approval of validation deliverables
- Partner with Site Engineering on deliverables
- Partner with Quality on deliverables
- Partner with Device Development on deliverables
- Partner with MSAT on deliverables
- Partner with User teams on deliverables
- Ensure seamless cross-functional coordination
- Ensure alignment among key project stakeholders
- Manage the full supplier relationship lifecycle
- Select suppliers
- Engage suppliers via contract
- Monitor supplier performance
- Review critical technical documentation from suppliers
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Automation/MES systems
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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