Qualification Validation Expert (m|f|d)

For more than 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to make a significant contribution to biomedical sciences. We encourage a creative working environment driven by pioneering spirit– to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 4,800 experts from over 75 countries contribute to our sustainable success. 

As a member of our Cell Factory Team, you will participate at our transition from our clinical to our commercial manufacturing of our cell and gene therapies, supporting the move to electronic records and witnessing this significant transformation first-hand. You will help ensure that our devices and systems in our cell factory comply with recognized Good Manufacturing Practice (GMP) standards, thereby directly impacting the delivery of personalized medicine to patients.

• Youwill support qualification, validation andlifecycle management activities for systems used across production, quality control and logistics at our GMP manufacturing site in Bergisch Gladbach.
• With astrong focus oncompliance anddocumentation, you willexecute anddocumentIQ/OQ/PQ activities for manufacturing equipment, utilities and laboratory systems,ensuring theirqualified statewithin a GMP-regulated environment.
• You willprepare,maintain andupdate qualification andvalidation documentation, including URS, risk assessments, test plans, reports and SOPs.
• Working closelywith experienced colleagues, you willcontribute toqualification andvalidation projects andsupport theimplementation of compliant and practical solutions.
• You willassist withGxP-related activities such as deviations, CAPAs and change controls while supporting continuous process improvements.

• Youhold adegree inLife Sciences, Biotechnologyor arelated discipline. Alternatively, you are qualified as a Biological Technical Assistant (BTA) or hold a comparable qualification.
• You have gained initial experience inqualification, validation,commissioning orsupporting IQ/OQ/PQ activities within aGMP-regulated environment.
• Experience with GMP requirements as well as in the pharmaceutical, biotechnology, medical device or other regulated industries would be advantageous.
• You are organized, work in a structured manner andenjoy supporting processimprovements in adynamic environment.
• As ateam player, you value open communication and collaboration with colleagues, customers and external partners.
• You arefluent in English andfeel comfortable working incross-functional andinternational teams.

What we offer

• Flexible and remote work: Enable time management on your terms
• Diversity: International teams and cross-border intercultural communication
• Room for creativity: It’s the most clever solution that we always strive for
• Health & Sport: We offer a wide range of corporate sports activities and health provision
• Miltenyi University: A clever mind never stops learning, take advantage of our in-house Training Academy

Diversity is the bedrock of our creativity.

Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots –across various disciplines, linking different perspectives, skills, and abilities.

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion, or disability.

Contact us

If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for.