Process Validation Engineer | Life Sciences

Capgemini; Diegem; Hybride; EUR 65 000 - 95 000; Plein temps

Avantages offerts par ce poste

Hybrid working

Learning platforms

Mentoring programs

FlexAbroad

Résumé du poste

Capgemini Engineering in Belgium seeks a Process Validation Engineer to drive validation activities for CAR-T cell therapy manufacturing in Ghent. You will define strategy, coordinate validation efforts, and ensure compliance with regulatory standards while supporting the transfer of this innovative therapy to Belgium.

The role offers collaboration with cross-functional teams, exposure to sterile manufacturing, and opportunities to optimize processes in a fast-paced environment.

Qualifications

• Master's degree in Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or related discipline.
• 2–5 years of experience in Pharmaceutical/Biotechnology/Cell Therapy.
• Experience with cGMP, process validation methodologies, and sterilization validation.

Responsabilités

• Define strategy, planning, and coordinate validation activities including hold time validation, APQ, APS, smoke studies, and process validation.
• Provide expert guidance on validation and qualification activities; assure revalidation of manufacturing and sterilization processes.
• Write, review, and approve process validation plans, protocols, and reports with focus on accuracy and compliance.
• Participate in product transfer and system introduction teams, supporting the CAR-T pilot plant in Ghent.
• Engage in system and process improvement across manufacturing operations; review technical reports for cGMP compliance.

Connaissances

cGMP knowledge

Process validation

Sterilization validation

Documentation

Cross-functional teamwork

English fluency

Dutch fluency

Formation

Master's degree in Engineering/biotech/pharmacy

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 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 RoleAs 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.In this role you will play a key role in: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 standardsProviding expert guidance on validation and qualification activities, assuring revalidation of manufacturing and sterilization processes in line with current industry and regulatory requirementsWriting, reviewing, and approving process validation plans, protocols, and reports — including APS and other related documentation — with a strong focus on accuracy, compliance, and clarityActively participating in product transfer and system introduction teams, contributing technical expertise to support the successful implementation of the CAR-T pilot plant in GhentEngaging in system and process improvement and optimisation projects, identifying opportunities to enhance efficiency, quality, and compliance across manufacturing operationsReviewing 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 technologyYour ProfileWe'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 disciplineIndustry 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 processesTechnical knowledge: Strong working knowledge of cGMP regulations, process validation methodologies, and sterilization validation; experience working in a controlled cleanroom or aseptic environment is a plusSoft 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 organisationLanguages: Fluency in English and DutchMobility: Three days onsite in GhentWhat You Will Love About Working HereFree 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.