Qualification Validation Expert (m|f|d): Play a key role in our manufacturing transition

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.