CAR-T QA C&Q EngineerAn 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 rationalescalibration master forms and recordsmaster data set-upmaintenance plansdata integrity activities such as audit trail and user access reviewsParticipate in regulatory and customer inspections and act as a QA representative for qualification activities .Review and approve qualification documentation such as:change controlsprotocols and reportsmaster documentsrationalesSOPsURS, IA, QSRdeviations 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 ProfileThe 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 .