Junior QA Micro Trainer | Life Sciences Ghent

Capgemini Engineering; Diegem; Sur place; EUR 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Mentoring programs

Global Tech challenges

Career acceleration programs

Résumé du poste

Capgemini Engineering in Ghent, Belgium is seeking a QA Micro trainer to oversee aseptic manufacturing of autologous CAR-T products within a cgmp cleanroom environment. You will be based in Ghent and lead training, aseptic qualification, and contamination control in close collaboration with operators and QC teams.

The role emphasizes hands-on training, shift work, and adherence to cGMP with opportunities to advance within Capgemini’s global engineering community.

Qualifications

• Bachelor’s or Master’s Degree in Science, Engineering or equivalent technical discipline is required.

Responsabilités

• Perform aseptic qualification of manufacturing personnel (e.g. gowning, aseptic processing) in the training lab and on the shop floor in Grade B cleanrooms.
• Define specific aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions.
• Drive the Aseptic Oversight program by execution of manufacturing floor surveillance.
• Identify risks and opportunities in relation to contamination control and assist in follow-up initiatives for improvement in close cooperation with operators, QC and operations management.

Connaissances

Aseptic handling

Teamwork

Organized

Attention to detail

Training mindset

Formation

Bachelor's or Master's in Science/Engineering

Description du poste

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide 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

CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.

As a QA Micro trainer, your will be responsible for providing microbiological and aseptic oversight and contamination control of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. The QA Micro trainer will be based in Ghent, Belgium. You will:

• Perform aseptic qualification of manufacturing personnel (e.g. gowning, aseptic processing) in the training lab and on the shop floor in Grade B cleanrooms.
• Define specific aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions.
• Drive the Aseptic Oversight program by execution of manufacturing floor surveillance.
• Identify risks and opportunities in relation to contamination control and assist in follow-up initiatives for improvement in close cooperation with operators, QC and operations management.

Your Profile

• Bachelor’s or Master’s Degree in Science, Engineering or equivalent technical discipline is required. Experience within the biological and/or pharmaceutical industry with relevant aseptic experience related to manufacturing is required.
• Open to work in shifts from 6 to 14 hour and from 12 to 20 hour.
• Passion for training and are willing to work in Grade B cleanrooms.
• Aseptic processing experience clean rooms.
• Basic knowledge of cGMP regulations and FDA/EU guidance related to aseptic manufacturing.
• Basic knowledge of the shop floor manufacturing process.
• Organized and capable of working in a team environment with a positive attitude under some supervision.
• Deal with procedures and guidelines that require strict application, as well as situations where not everything is clear yet.

What You Will Love About Working Here

• Mentoring programs: Capgemini empowers women at all career stages with programs spanning STEM education to career reentry. We value mentorship for fostering professional growth and empowerment within our engineering community.
• Global Tech challenges: Capgemini hosts annual group-wide competitions, such as the Global Data Science Challenge and Tech4PositiveFutures. These aim to address world issues like climate change and biodiversity by applying technology for innovative solutions. The Future of X is a Global Ideation Campaign that look for ideas for iconic anchor R&I projects and demonstrators of Technology. Winning ideas were funded up to 100K€.
• Career acceleration programs: From associate to leaders and beyond, get support in your career at every stage with award-winning programs such as our leadership development program, Connected Manager, to accelerate your growth and develop your expertise.

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 fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.