CAR-T Compliance and Qualification Engineer | Life Sciences

Capgemini; Diegem; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Flexible work arrangements

Career development programs

Inclusivity networks

Résumé du poste

A global technology and consulting firm is seeking a CAR-T Compliance and Qualification Engineer to oversee compliance and qualification activities in advanced cell therapy manufacturing. The ideal candidate will have a Bachelor's degree in engineering or pharmaceutical sciences and 4-6 years of relevant experience in quality assurance. Flexible work arrangements are available, promoting a balanced work-life. Join a diverse community where innovation thrives.

Qualifications

• 4-6 years of experience in quality assurance, preferably in pharmaceutical or cell therapy manufacturing.
• Strong awareness of quality principles and familiarity with cGMP regulations and FDA/EU guidance.
• Experience with system configurations and data management.

Responsabilités

• Oversee qualification and compliance activities for critical production assets.
• Collaborate with Engineering teams to maintain assets in a validated state.
• Review and approve qualification documentation including protocols and reports.

Connaissances

Quality assurance

Analytical thinking

Risk assessment

Formation

Bachelor's degree in engineering or pharmaceutical sciences

Outils

Computerized systems

Description du poste

Choose a partner with intimate knowledge of your industry and first-hand experience of defining its future.Your locationYour locationIndustriesChoose a partner with intimate knowledge of your industry and first-hand experience of defining its future.Diegem# CAR-T Compliance and Qualification Engineer | Life Sciences## Job DescriptionAt Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.**Your role**In this role, you will oversee qualification and compliance activities for facilities, utilities, and process equipment in advanced cell therapy manufacturing. You will play a key role in ensuring that critical production assets remain in a validated and compliant state while supporting quality excellence in a highly regulated environment.In this role you will play a key role in:* Collaborating with Asset Management and Engineering teams to maintain critical production assets in a validated and compliant state* Evaluating and investigating deviations related to equipment issues with potential quality or compliance impact* Reviewing and approving change controls while partnering with manufacturing teams* Managing compliance status of production assets through review of calibration rationales, maintenance plans, and data integrity deliverables* Approving qualification documentation including protocols, reports, rationales, SOPs, and user requirement specifications**Your profile*** Bachelor's degree in engineering (chemistry, analytical orientation), pharmaceutical sciences, or equivalent* 4-6 years of experience in quality assurance, preferably in pharmaceutical or cell therapy manufacturing* Strong awareness of quality principles and familiarity with cGMP regulations and FDA/EU guidance* Experience with computerized systems, system configurations, and data management in critical production environments* Excellent analytical thinking, risk assessment capabilities, and clear communication skills**What you'll love about working here*** Flexible work arrangements: Work from home up to 70% of the time, plus our FlexAbroad program lets you work up to 45 days from another country for better work-life balance* Career development: Access diverse growth programs and career paths designed to help you explore new opportunities* Inclusive community: Join employee-led networks like OUTfront, Women@Capgemini, or CapAbility that promote diversity, equity, and inclusion in our workplace and beyond**About Capgemini**Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fuelled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.Experience levelExperienced ProfessionalsLocationDiegem