1201 F. Hoffmann-La Roche AG
Global MSAT DP Pilot Plant Bioprocess Scientist / Engineer(m/w/x)
Full-timeOn-siteSenior
Basel
New Job?Nejo!
The AI Job Search Engine
121201 F. Hoffmann-La Roche AG
Device Process Engineer - Global MSAT(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Design transfer and scalability for medical devices and drug-device combination products at a global pharmaceutical company, utilizing DoE and DFM/DFA/DFx assessments. 7+ years in medical device or drug-device process engineering required, with hands-on expertise in Device Assembly, Final Sterilization, or Final Packaging/Labeling essential. Global MSAT scope, focusing on advanced manufacturing technologies.
Requirements
- B.S. or M.S. in Mechanical, Biomedical, Pharmaceutical Engineering, or related technical discipline
- 7+ years of experience in process engineering within medical device or drug-device combination product development
- Hands-on expertise in Device Assembly, Final Sterilization, or Final Packaging/Labeling
- Demonstrated ability to lead technology scaling and New Product Introduction (NPI)
- Advanced proficiency in statistical data analysis, Quality by Design (QbD), and risk management tools
- Exceptional communication and negotiation skills
Tasks
- Lead design transfer of medical devices and drug-device combination products
- Ensure seamless scalability between development and commercial-scale production
- Utilize Design of Experiments (DoE) to evaluate Critical Process Parameters (CPPs)
- Conduct Design for Manufacturability, Assembly, and Excellence (DFM/DFA/DFx) assessments
- Leverage advanced manufacturing technologies for robust process development
- Define Process Performance Qualification (PPQ) and Quality Control strategies
- Author and manage risk documentation using FMEA and Tolerance Analysis
- Lead technical investigations into process deviations or design issues
- Provide technical oversight for existing products and recommend process enhancements
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- cGMP
- ISO 13485
- FDA 21 CFR Part 4
- FDA 21 CFR Part 820
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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.
Not a perfect match?
- 1201 F. Hoffmann-La Roche AG
Global MSAT DS Senior Process Steward(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior DP (Drug Product) Product Steward - Global MSAT(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Full-timeOn-siteManagementBasel - F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Full-timeOn-siteSeniorBasel
121201 F. Hoffmann-La Roche AG
Device Process Engineer - Global MSAT(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Design transfer and scalability for medical devices and drug-device combination products at a global pharmaceutical company, utilizing DoE and DFM/DFA/DFx assessments. 7+ years in medical device or drug-device process engineering required, with hands-on expertise in Device Assembly, Final Sterilization, or Final Packaging/Labeling essential. Global MSAT scope, focusing on advanced manufacturing technologies.
Requirements
- B.S. or M.S. in Mechanical, Biomedical, Pharmaceutical Engineering, or related technical discipline
- 7+ years of experience in process engineering within medical device or drug-device combination product development
- Hands-on expertise in Device Assembly, Final Sterilization, or Final Packaging/Labeling
- Demonstrated ability to lead technology scaling and New Product Introduction (NPI)
- Advanced proficiency in statistical data analysis, Quality by Design (QbD), and risk management tools
- Exceptional communication and negotiation skills
Tasks
- Lead design transfer of medical devices and drug-device combination products
- Ensure seamless scalability between development and commercial-scale production
- Utilize Design of Experiments (DoE) to evaluate Critical Process Parameters (CPPs)
- Conduct Design for Manufacturability, Assembly, and Excellence (DFM/DFA/DFx) assessments
- Leverage advanced manufacturing technologies for robust process development
- Define Process Performance Qualification (PPQ) and Quality Control strategies
- Author and manage risk documentation using FMEA and Tolerance Analysis
- Lead technical investigations into process deviations or design issues
- Provide technical oversight for existing products and recommend process enhancements
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- cGMP
- ISO 13485
- FDA 21 CFR Part 4
- FDA 21 CFR Part 820
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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.
About the Company
1201 F. Hoffmann-La Roche AG
Industry
Healthcare
Description
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
Not a perfect match?
- 1201 F. Hoffmann-La Roche AG
Global MSAT DP Pilot Plant Bioprocess Scientist / Engineer(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Global MSAT DS Senior Process Steward(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior DP (Drug Product) Product Steward - Global MSAT(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Full-timeOn-siteManagementBasel - F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Full-timeOn-siteSeniorBasel