Job Description
As a member of our Cell Factory Team, you will play a key role in 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 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.
* You will plan, coordinate and execute the qualification, validation and lifecycle management of different systems across production, quality control and logistics at our GMP manufacturing site in Bergisch Gladbach.
* With a strong focus on accuracy and compliance, you will prepare, maintain and manage qualification and validation documentation, including URS, risk assessments, IQ/OQ plans, reports and SOPs.
* Acting as a trusted partner, you will advise internal subject matter experts on qualification and validation projects, propose pragmatic solutions and actively support their successful implementation.
* You will contribute to GxP activities such as deviations, CAPAs and change control, while continuously enhancing qualification and validation-related processes.
* You will collaborate closely with internal stakeholders (e.g. IT, QA, QC, Manufacturing) as well as external service providers and equipment manufacturers to ensure efficient, compliant workflows.
* By planning and conducting training sessions resulting from qualification and validation activities you will ensure sustainable knowledge transfer and compliance.
Qualifications
* You hold a degree in life sciences, engineering or a comparable technical field or have completed a similar qualification in a corresponding field.
* Regulatory topics such as GMP and FDA guidelines are familiar territory and hands-on experience in qualifying systems (e.g. equipment, media/utilities or rooms) in the pharmaceutical industry or other regulated environments would be a strong plus.
* You will bring structure into a dynamic environment and take initiative when improving processes.
* You are a team player; you value open communication with colleagues, customers and external suppliers alike.
* You are fluent in English and feel comfortable collaborating across functions and cultures.
Additional Information
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.