Job Description

Bei Roche kannst du ganz du selbst sein und wirst fur deine einzigartigen Qualitaten geschatzt. Unsere Kultur fordert personlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du fur das, was du bist, wertgeschatzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl personlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat - heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zahlt.


Die Position
The Global MSAT & Engineering (PTT) function is undergoing a massive, multi-site modernization initiative. We are taking bold steps to introduce innovative, efficient, and sustainable equipment and technology across our global device manufacturing landscape.

As a Senior Process Engineer, you are the driving force behind the implementation of next-generation processes.

The opportunity

This critical role requires deep technical insight into device manufacturing--including assembly, sterilization, and packaging--to ensure robust, future-ready workflows and the reliable, compliant distribution of our products across the entire lifecycle.


Design Transfer & Industrialization:

Lead design transfer of medical devices and drug-device combination products (e.g., autoinjectors, pens, needle safety devices) from development into internal and external manufacturing sites. Ensure seamless scalability by bridging the gap between development and commercial-scale production.


Process Engineering & Optimization:


Process Development & Characterization: Utilize Design of Experiments (DoE) to identify and evaluate Critical Process Parameters (CPPs), ensuring a deep understanding of how process variances impact product performance. Drive DFx Excellence: Conduct Design for Manufacturability, Assembly, and Excellence (DFM/DFA/DFx) assessments to optimize assembly, sterilization, and packaging operations. Advanced Technology Integration: Leverage state-of-the-art manufacturing technologies to develop robust processes for both clinical and commercial production.


Quality, Validation & Risk Management:

Strategy Development: Define Process Performance Qualification (PPQ) and Quality Control strategies. Risk Mitigation: Author and manage risk documentation, utilizing FMEA (Failure Mode and Effects Analysis) and Tolerance Analysis to ensure high process capability

Continuous Improvement & Investigation:


Root Cause Analysis: Lead technical investigations into process deviations or design issues using structured methodologies. Sustaining Engineering: Provide technical oversight for existing products, recommending process enhancements for sterilization, labeling, and packaging to maintain optimal performance.

Who you are

You have a B.S. or M.S. in Mechanical, Biomedical, Pharmaceutical Engineering, or a related technical discipline, you have worked in the pharmaceutical industry and you bring the following qualification:

7+ years of experience in process engineering, specifically within medical device or drug-device combination product development and industrialization with proven track record with complex delivery systems, such as pre-filled syringes, needle safety devices, and autoinjectors/pen injectors. Hands-on expertise in Device Assembly, Final Sterilization, or Final Packaging/Labeling. Demonstrated ability to lead technology scaling and New Product Introduction (NPI), moving seamlessly from early-stage feasibility through to commercial-scale manufacturing. Advanced proficiency in statistical data analysis, Quality by Design (QbD), and risk management tools, with a focus on developing comprehensive FMEAs, and solid command of cGMP, ISO 13485, and FDA 21 CFR Part 4/Part 820 regulations. Exceptional communication and negotiation skills, with the ability to influence cross-functional stakeholders in a matrixed environment, with fluent English (ability to travel internationally -approx. 10-20%- to support Factory Acceptance Testing (FAT) and on-site implementation at manufacturing facilities)

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!



Wer wir sind
Eine gesundere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat - heute und fur zukunftige Generationen. Durch unser Engagement werden uber 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgefuhrt. Wir ermutigen uns gegenseitig, neue Moglichkeiten zu erkunden, Kreativitat zu fordern und hohe Ziele zu setzen, um lebensverandernde Gesundheitslosungen zu liefern.


Gemeinsam konnen wir eine gesundere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fordert.