Process Engineer (2 Jahre Temporär)

Process Engineer Downstream

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 engineer downstream in the manufacturing unit Bau 91, you will deliver solutions for the ADC area (antibody-drug conjugates) at Basel drug substance manufacturing for a safe and high-quality production. You will serve both our patients and our employees in the manufacturing unit by developing and implementing process improvements, fostering dialogue and collaboration between global functions in the areas of development, innovation, and regulatory, and exchanging information with other production sites of Roche. As part of the process engineer community within Basel drug substance, it is also possible that you will be deployed in the other area (SUT Bau91 and MAB Bau95).

The Opportunity

You will take over the technical and scientific support (1st and 2nd line support) of ADC to ensure robust and efficient manufacturing processes in the GMP environment. Furthermore:

• On-call duty (pikett) as 1st and 2nd level manufacturing support

• Planning and coordination of troubleshooting activities and root cause analysis in close cooperation with the manufacturing value streams, quality, and support units

• Handling of planned and unplanned events according to GMP guidelines (planned/unplanned events)

• Review and approval of electronic batch protocols for commercial and clinical products (MES based batch record review)

• Acting in accordance with the requirements of the internal quality system and the cGMP regulations of health authorities

• Owner of the production processes (interface areas manufacturing, science and technology (MSAT))

• Creation and presentation of concepts, documents, and assessments at GMP audits and authority inspections

Who You Are

You have a completed degree (preferably in natural or engineering sciences) or a degree in biotechnology or bioprocess technology. Furthermore:

• Extensive knowledge in the area of downstream processing of biotechnologically produced products

• At least 2 years of experience in biopharmaceutical manufacturing or development (experience in the ADC area preferred)

• Fluent German skills in speech and writing

• Hands-on experience in large molecules or ADC drug substance manufacturing processes in steel or single-use technology is advantageous

• Team player with a very high degree of independence in a self-directed environment

• Experience in working in a cGMP environment

• Experience in technical transfers and in quality risk management (QRM) is advantageous

Be part of a great team, apply now!

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.