Senior Engineer - Design Control Excellence
Roche
About the role
About Roche
Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich 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 zählt.
The Position
As a Process Manager, you are responsible for essential development processes including Requirement Management, Product Risk Management, Configuration Management, Verification & Validation, and Defect Management. This role ensures the compliant execution of these processes within development projects—encompassing full documentation—while continuously optimizing efficiency to meet evolving organizational needs.
The Opportunity
- Process Governance: Lead process guidance, optimization, and documentation for system-, software-, and assay-projects across Risk, Requirements, Configuration, and Defect Management.
- Requirements & Traceability: Support multi-level requirements traceability and ensure all data is maintained within a streamlined database approach across projects.
- Risk Assessment: Conduct detailed product risk assessments by analyzing documents, reports, and market trends alongside cross-functional teams to ensure high-quality documentation.
- Configuration Management: Establish beneficial Configuration Management for complex projects, keeping the overview about past, present and future Product Configurations.
- Verification & Validation: Provide specialized Verification know-how, including planning, guiding, training, and reporting.
- Defect Management: Act as the primary Defect Manager for development projects, ensuring timely resolution and high-quality process execution.
- Stakeholder Collaboration: Manage project interactions between Development, Production, Customer Service, Quality, Regulatory, and external suppliers to gather and consolidate critical information.
- Task Execution: Execute work packages independently, managing your own timelines to ensure the delivery of timely, high-quality project documentation.
Who You Are
- Educational Background: University degree in Life Sciences, Natural Sciences, or Engineering, complemented by at least two years of experience in Process Management.
- Industry Expertise: Proven experience in Risk, Requirements, Defect, or Configuration Management, with a preference for candidates from the Diagnostics industry.
- Analytical Leadership: Strong analytical thinking with the ability to lead by influence, drive decisions, resolve conflicts, and instill a sense of urgency in teams.
- Communication Skills: Excellent presentation and communication skills in English (verbal and written), with proficiency in German and database experience being highly preferred.
- Collaborative Mindset: An open‑minded team player with a structured, reliable working manner and the ability to prioritize multiple tasks in a changing environment.
Ready for the Next Step?
We look forward to hearing from you. Apply now to discover this exciting opportunity!
Wer wir sind
Eine gesündere 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 für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik‑Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Equal Opportunity Employer
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
Requirements
- University degree in Life Sciences, Natural Sciences, or Engineering.
- At least two years of experience in Process Management.
- Proven experience in Risk, Requirements, Defect, or Configuration Management.
- Strong analytical thinking with the ability to lead by influence, drive decisions, resolve conflicts, and instill a sense of urgency in teams.
- Excellent presentation and communication skills in English (verbal and written).
- An open-minded team player with a structured, reliable working manner and the ability to prioritize multiple tasks in a changing environment.
Responsibilities
- Lead process guidance, optimization, and documentation for system-, software-, and assay-projects across Risk, Requirements, Configuration, and Defect Management.
- Support multi-level requirements traceability and ensure all data is maintained within a streamlined database approach across projects.
- Conduct detailed product risk assessments by analyzing documents, reports, and market trends alongside cross-functional teams to ensure high-quality documentation.
- Establish beneficial Configuration Management for complex projects, keeping the overview about past, present and future Product Configurations.
- Provide specialized Verification know-how, including planning, guiding, training, and reporting.
- Act as the primary Defect Manager for development projects, ensuring timely resolution and high-quality process execution.
- Manage project interactions between Development, Production, Customer Service, Quality, Regulatory, and external suppliers to gather and consolidate critical information.
- Execute work packages independently, managing your own timelines to ensure the delivery of timely, high-quality project documentation.
Skills
Don't send a generic resume
Paste this job description into Mimi and get a resume tailored to exactly what the hiring team is looking for.
Get started free