CAR-T QA C&Q Engineer
An innovative global biopharmaceutical company is looking for a CAR-T QA C&Q Engineer to support advanced cell therapy manufacturing in Europe.
CAR-T (Chimeric Antigen Receptor T-cell Therapy) is an advanced treatment that uses a patient’s own immune cells to target and eliminate cancer cells expressing specific antigens.
To support the expansion of the CAR-T program in the EMEA region, multiple state-of-the-art manufacturing facilities have been established in Europe, supported by centralized quality control laboratories.
The CAR-T QA C&Q Engineer will be part of the QA Qualification team and will be responsible for the review and approval of qualification and requalification activities related to Facilities & Utilities (F&U) and Process Equipment within advanced cell therapy manufacturing operations.
Job Responsibilities
The successful candidate will:
* Work closely with asset management and engineering teams to maintain the qualification status of critical production assets.
* Ensure that all critical aspects related to facilities, utilities, product and process requirements are identified, qualified, and properly controlled through mitigation plans.
* Review and assess deviations related to equipment issues that may impact quality or compliance and ensure appropriate corrective and preventive actions (CAPA) are implemented.
* Collaborate with the manufacturing department to review and approve change controls and investigate deviations with potential impact on product quality or compliance.
* Build strong collaboration across different quality and operational organizations.
* Maintain the compliance status of critical production assets through review and approval of:
* calibration rationales
* calibration master forms and records
* master data set-up
* maintenance plans
* data integrity activities such as audit trail and user access reviews
* Participate in regulatory and customer inspections and act as a QA representative for qualification activities.
* Review and approve qualification documentation such as:
* change controls
* protocols and reports
* master documents
* rationales
* SOPs
* URS, IA, QSR
* deviations and related corrective actions during qualification execution.
* Support system and process improvement initiatives while ensuring compliance with international regulations, guidelines, and industry best practices.
* Act as a QA subject matter expert within the qualification process.
Candidate Profile
The ideal candidate has:
* A Master’s degree in Engineering (chemistry or analytical background) or Pharmaceutical Sciences.
* Strong quality awareness and knowledge of cGMP regulations and FDA/EU guidance related to cell therapy manufacturing.
* The ability to defend quality strategies and documentation during health authority inspections.
* Affinity with computerized systems, system parameter configurations, and data management for critical production assets.
* Strong communication skills and the ability to collaborate across departments in a dynamic and evolving environment.
* Fluency in Dutch and English, both written and spoken.
* Strong analytical thinking, risk assessment, and problem-solving skills.