Quality Assurance Engineer - CAR-T at Clinchoice

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a CAR-T Quality Assurance Engineer to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) temporary employment position to the end of 2026 initially. The Engineer will be responsible for the review and approval of qualification and requalification activities, related to Facilities and Utilities and Process Equipment at our client’s facility in Ghent. ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. Main Job Tasks and Responsibilities: • Work closely with the Make Asset Management and Engineering & Property Services department to guard the qualification status of critical production assets by ensuring that all system critical aspects related to facilities and utilities, product and process requirements are identified; qualified and controlled by a mitigation plan and ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventative actions are defined and implemented. • Work closely together with the manufacturing department to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented. • Build strong connections with different quality organizations. • Manage the compliance status of critical production assets by means of review and approval of procedures e.g. calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviews. • Participate in the preparation for regulatory and customer inspections and act as a spokesperson for Quality Assurance qualification. • Approve qualification documents (change controls, master documents, protocols, reports, rationales, SOP’s, URS, IA, QSR, etc.) including discrepancies/events/non-conforming situations and related corrective actions (correction, CPA) occurring during execution of qualification activities. • Participate in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert. Education, Experience and Skills: · Master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences · Awareness of quality; have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products and you see it as a challenge to defend our strategy and documents towards health authority inspections. · Affinity with computerized systems, System parameter configurations and data management in critical production assets. · Ability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environment. · Thorough knowledge of Dutch and English, both orally and in writing · Strong analytical thinking, risk assessment, and communication skills · Collaboration and teaming skills The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Quality Assurance Engineer, CAR-T, QA Officer, Quality Officer, Quality Assurance Specialist, QA Specialist, Temporary# #LI-LG1