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.