Roche

Senior Engineer - Design Control Excellence

Rotkreuz Full time

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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


In this role, your main responsibilities will consist of the following key activities to drive project success and compliance:

  • 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

We are looking for a candidate who meets the following qualifications and brings a proactive, structured mindset to our team:

  • 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!

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.