Quality Engineering Expert

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

The Quality Engineering Expert, within Network Quality Engineering, is responsible for the technical execution of quality oversight across our manufacturing network. This role ensures that drug product and substance manufacturing assets—including equipment, utilities, and systems—remain in a constant state of compliance, reliability, and "inspection readiness" through rigorous standardization and lifecycle management.

The Opportunity

This role is responsible for the end-to-end quality oversight of manufacturing assets, equipment, and utilities. The Quality Engineering Expert ensures that all engineering requirements are met through direct collaboration with Site Quality teams and cross-functional partners. The role focuses on the technical integrity of equipment throughout its lifecycle, ensuring compliant, efficient, and high-performing manufacturing solutions.

As a Quality Partner for PTM, PTT, and manufacturing sites, the Quality Engineering Expert provides high-level technical support to ensure the completion of Quality deliverables. This role acts as the Quality Single Point of Contact (QSPOC) to provide technical quality oversight for device and packaging projects, ensuring the cohesive qualification and calibration of assets and equipment for devices and combination products. Providing specialized oversight for:

• Capital Projects: Quality input for new assets, greenfield projects, facility design, qualification, and validation.
• System Architecture: Designing fit-for-purpose, compliant, and efficient systems for manufacturing.
• Compliance & Risk: Establishing GMP oversight consistent with internal policies and external regulations, proactively mitigating risks through early engagement
• Technical quality oversight of a pilot plant focused on medical devices and drug-device combination products
• Preventive Maintenance: Support strategies for comprehensive maintenance programs to ensure equipment, utilities, and systems operate reliably. Monitors effectiveness and recommends technical improvements.
• Lifecycle Qualification: Oversees the qualification of equipment and utilities, ensuring they meet regulatory standards (FDA, EMA, GMP) before and during their operational lifecycle.
• Calibration Oversight: Establishes monitoring strategies for standardized calibration programs to ensure data integrity and manage complex non-conformances.
• Critical Utilities Management: Provides technical oversight for HVAC, water systems, compressed air, and steam to ensure they consistently meet quality and regulatory performance standards.

Who You Are

You hold a Bachelor's or Master in Life Sciences, Engineering, or Chemistry and bring over 10 years of experience in quality engineering within a pharma or biotech manufacturing environment. You have a proven track record in aseptic manufacturing, as well as expertise in medical devices and combination products.

• Deep technical expertise in the qualification of assets and equipment utilized in device and combination product manufacturing, supported by a strong background in preventive maintenance, calibration, and critical utilities management under GMP, FDA, and EMA regulations.
• Strong communication and interpersonal skills, with the ability to work collaboratively across multiple sites and clearly convey technical information.
• Proven experience in managing cross-functional projects, including standardization initiatives and quality improvement programs.
• High level of attention to detail and commitment to ensuring the highest standards of quality.
• Proficiency in English is required; German is a plus

Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!

The role is levelled as SE7; depending on the seniority of the selected candidate, we are open to hiring on SE6 or SE7. 

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.