1201 F. Hoffmann-La Roche AG
Global MSAT DP Pilot Plant Bioprocess Scientist / Engineer(m/w/x)
Vollzeitnur vor OrtSenior
Basel
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121201 F. Hoffmann-La Roche AG
Device Process Engineer - Global MSAT(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP
- ISO 13485
- FDA 21 CFR Part 4
- FDA 21 CFR Part 820
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 1201 F. Hoffmann-La Roche AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- 1201 F. Hoffmann-La Roche AG
Global MSAT DS Senior Process Steward(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior DP (Drug Product) Product Steward - Global MSAT(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Vollzeitnur vor OrtManagementBasel - F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSeniorBasel
121201 F. Hoffmann-La Roche AG
Device Process Engineer - Global MSAT(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP
- ISO 13485
- FDA 21 CFR Part 4
- FDA 21 CFR Part 820
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 1201 F. Hoffmann-La Roche AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
1201 F. Hoffmann-La Roche AG
Branche
Healthcare
Beschreibung
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
Noch nicht perfekt?
- 1201 F. Hoffmann-La Roche AG
Global MSAT DP Pilot Plant Bioprocess Scientist / Engineer(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Global MSAT DS Senior Process Steward(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior DP (Drug Product) Product Steward - Global MSAT(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Vollzeitnur vor OrtManagementBasel - F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSeniorBasel