Qualification Engineer/qualifizierungsingenieur (m/w/d)

Roche Job Opportunity

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

Medikamente schnell zu den Patienten zu bringen und das beste Ergebnis für unsere Kunden zu schaffen. Das ist es, was uns in Sterile Drug Product Manufacturing (SDPM) in Mannheim antreibt. So tragen wir auch dazu bei, bis 2029 unser Ziel zu erreichen: 20 bahnbrechende Medikamente zur Behandlung der Krankheiten mit der größten gesellschaftlichen Belastung bereitzustellen. Unsere Arbeit, unser täglicher Einsatz und unser Engagement bedeuten für sehr viele Menschen große Hoffnung und Zuversicht und deswegen müssen wir anders denken und arbeiten. Mit dem Patient im Fokus setzen wir auf eine neue Organisation und zwar #WIRGEMEINSAM in SDPM!

What You Can Expect

As a Qualification Engineer/Qualifizierungsingenieur (m/w/d) you are part of the MSAT team and work together with colleagues to ensure our pharmaceutical plants run smoothly and all legal and GMP requirements are met. Become part of a team that not only ensures the highest standards are met but also actively promotes a culture of collaboration, lean management, and continuous improvement (#WIRGEMEINSAM).

In addition, you will take on the following exciting tasks:

• You create and are responsible for qualification and requalification documents such as plans, reports, and risk analyses for production facilities and equipment based on applicable requirements, regulatory guidelines, and validation concepts.
• You represent your work confidently during internal and external inspections and audits with authorities such as the EMA and FDA.
• You support the development of qualification concepts towards a continuous, data-driven qualification to increase efficiency.
• You efficiently manage, commission, and control external service providers and internal interface departments.
• You proactively exchange information with other locations to further develop the field and establish best practices.

Who You Are

• You have a completed technical degree (Bachelor, Master) in pharmaceutical technology, biotechnology, process engineering, or a relevant vocational training with several years of professional experience.
• You have extensive experience in the pharmaceutical industry, particularly in the field of sterile production and qualification.
• You have in-depth knowledge of pharmaceutical manufacturing processes and technologies as well as GMP, EU, and FDA guidelines and relevant pharmacopoeias.
• You are convincing with your fluent language skills and expressiveness in German and English (verbally and in writing).
• You possess a high level of teamwork and responsibility.
• The ability to think interdisciplinary, resolve conflicts, and integrate and convince round out your profile.

So far so good? It gets even better. We offer you diverse top benefits at our locations. Only together with you can we improve the lives of patients. You make Roche unique with your contribution. That's why we offer exceptional benefits that support you in shaping your life, finances, and health as you wish. Find out more here:

https://go.roche.com/Kandidaten-Benefits-DE

Your application

We ask for the following documents:

• Current resume or Workday profile
• Your official (educational) certificates & proofs

Further documents are currently not required. Please note before sending your application that no further documents can be added afterwards.

Apply now – we look forward to it!

Do you need further support?

Please have a look at our FAQs, you will find them via https://careers.roche.com/global/en/faq.

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.