Process Validation Engineer | Life Sciences

Capgemini Engineering; Diegem; Hybride; EUR 55 000 - 90 000; Plein temps

Avantages offerts par ce poste

Hybrid working

Mentoring programs

Free learning platforms

Global company

Résumé du poste

Capgemini Engineering seeks a Process Validation Engineer to support start-up and scale-up of CAR-T therapy manufacturing in Ghent. You will collaborate with cross-functional teams to ensure regulatory and quality standards for validation activities and support US-to-Belgium transfers.

You will define validation strategies, write plans and oversee reports, while contributing to transfer projects and site improvements in a highly regulated environment.

Qualifications

• Master's degree in Engineering, Biotechnology, Biomedical Sciences, Pharmacy or related discipline.
• 2–5 years in Pharmaceutical/Biotech/Cell Therapy with manufacturing exposure.
• Strong knowledge of cGMP and validation; aseptic environment experience a plus.

Responsabilités

• Define strategy and plan validation activities (hold time, APQ, APS, smoke studies, process validation).
• Provide expert guidance on validation and qualification; ensure revalidation of processes.
• Write, review and approve validation plans, protocols and reports with accuracy and compliance.
• Support product transfer and system introduction for the CAR-T pilot plant in Ghent.
• Drive system/process improvements to boost efficiency, quality, and compliance.
• Review technical reports to ensure adherence to cGMP and regulatory requirements.

Connaissances

Problem solving

Teamwork

Communication

Independent work

Formation

Master's degree

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 arethe same.

Your Role

As a Process Validation Engineer, you will be a key contributor to the successful start-up and scale-up of CAR-T cell therapy manufacturing in Ghent. Working closely with cross-functional teams, you will help ensure that all validation activities meet the highest regulatory and quality standards, supporting the transfer of this innovative therapy from the US to Belgium.

• Defining strategy, planning, and coordinating validation activities including hold time validation, Annual Product Quality (APQ), Annual Product Summary (APS), smoke studies, and process validation, ensuring all activities are delivered on time and to the highest standards
• Providing expert guidance on validation and qualification activities, assuring revalidation of manufacturing and sterilization processes in line with current industry and regulatory requirements
• Writing, reviewing, and approving process validation plans, protocols, and reports — including APS and other related documentation — with a strong focus on accuracy, compliance, and clarity
• Actively participating in product transfer and system introduction teams, contributing technical expertise to support the successful implementation of the CAR-T pilot plant in Ghent
• Engaging in system and process improvement and optimisation projects, identifying opportunities to enhance efficiency, quality, and compliance across manufacturing operations
• Reviewing technical reports and other sources of information to ensure validations and procedures are consistent with current Good Manufacturing Practices (cGMP), regulatory requirements, and the latest industry technology

Your Profile

We're looking for a motivated and detail-oriented engineer with a passion for life sciences and a drive to make a difference in patients' lives. You bring both technical expertise and strong interpersonal skills, thriving in a dynamic, cross-functional environment.

• Educational background: A Master's degree Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or a related discipline
• Industry experience: 2-5 years of experience in the Pharmaceutical, Biotechnology, Cell Therapy, human plasma-derived products, or related industry, with hands-on knowledge of manufacturing site unit operations and product introduction processes
• Technical knowledge: Strong working knowledge of cGMP regulations, process validation methodologies, and sterilization validation; experience working in a controlled cleanroom or aseptic environment is a plus
• Soft skills & ways of working: A collaborative team player with strong problem-solving skills, the ability to work independently under general direction, manage competing priorities under pressure, and communicate effectively across all levels of the organisation
• Languages: Fluency in English and Dutch
• Mobility: Three days onsite in Ghent

What You Will Love About Working Here

• Free access to learning platforms Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more.

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.

Hybrid working

We encourage flexibility when it comes to when and where work gets done. Employees work with their managers to determine an arrangement that works best for their role and personal circumstances.

FlexAbroad

Employees in 20+ countries can work abroad for up to 45 days in a 12-month period.

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.