Upstream Process Engineer | Life Sciences

Capgemini; Diegem; Sur place; EUR 65 000 - 95 000; Plein temps

Résumé du poste

Capgemini Engineering in Belgium is seeking an Upstream SME to lead equipment validation and SAT activities, translating process requirements into qualification protocols and supporting commissioning. You will author and review GMP documentation in French and English to ensure clear, compliant materials for production teams.

The role involves contributing to GMP and campaign readiness for a new facility, collaborating with operators, validation engineers, and cross-functional stakeholders in

Qualifications

• Minimum of 2 years of experience in cell culture processes, upstream process development, manufacturing operations, and process equipment — ideally with exposure to viral vector or gene therapy manufacturing (e.g. AAV).
• Experience authoring manufacturing procedures, process descriptions and risk assessments, and familiarity with equipment qualification activities (SAT/IQ/OQ) in a regulated environment.
• Bilingual communication skills with full professional fluency in both French and English (spoken and written).
• Strong interpersonal and organizational skills, with the ability to manage multiple priorities under tight timelines, communicate clearly with multidisciplinary stakeholders, and bring a pragmatic, autonomous mindset to complex challenges.
• A scientific or technical degree (Engineering or Master's level preferred) in bioengineering, biochemistry, biotechnology or a related field.

Responsabilités

• Acting as the Upstream SME during equipment validation and Site Acceptance Testing (SAT) activities, ensuring that process requirements are correctly translated into qualification protocols and supporting troubleshooting during commissioning phases.
• Authoring and reviewing critical GMP documentation including operating procedures, process descriptions, risk assessments, and batch documentation in both French and English, producing clear and user-friendly materials for production teams.
• Contributing to GMP and campaign readiness activities for the new facility, supporting the preparation of mock runs and engineering runs in collaboration with cross-functional teams.
• Collaborating closely with manufacturing operators, validation engineers, process experts and project stakeholders across both French-speaking and English-speaking environments.
• Supporting strategic process and operational decisions depending on seniority, and contributing to cross-functional discussions on campaign setup and facility readiness.

Connaissances

Upstream Bioprocessing

GMP Documentation

Cross-functional teamwork

French English bilingual

Process validation

Formation

Bioengineering 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

• Acting as the Upstream SME during equipment validation and Site Acceptance Testing (SAT) activities, ensuring that process requirements are correctly translated into qualification protocols and supporting troubleshooting during commissioning phases.
• Authoring and reviewing critical GMP documentation including operating procedures, process descriptions, risk assessments, and batch documentation in both French and English, producing clear and user-friendly materials for production teams.
• Contributing to GMP and campaign readiness activities for the new facility, supporting the preparation of mock runs and engineering runs in collaboration with cross-functional teams.
• Collaborating closely with manufacturing operators, validation engineers, process experts and project stakeholders across both French-speaking and English-speaking environments.
• Supporting strategic process and operational decisions depending on seniority, and contributing to cross-functional discussions on campaign setup and facility readiness.

Your Profile

We’re looking for a proactive, solution-oriented engineer who combines solid upstream bioprocessing knowledge with excellent communication and documentation skills. You thrive in a fast-paced GMP environment and are equally comfortable working independently and as part of a team.

• Minimum of 2 years of experience in cell culture processes, upstream process development, manufacturing operations, and process equipment — ideally with exposure to viral vector or gene therapy manufacturing (e.g. AAV).
• Experience authoring manufacturing procedures, process descriptions and risk assessments, and familiarity with equipment qualification activities (SAT/IQ/OQ) in a regulated environment.
• Bilingual communication skills with full professional fluency in both French and English (spoken and written), enabling effective collaboration across diverse, multicultural teams.
• Strong interpersonal and organizational skills, with the ability to manage multiple priorities under tight timelines, communicate clearly with multidisciplinary stakeholders, and bring a pragmatic, autonomous mindset to complex challenges.
• A scientific or technical degree (Engineering or Master's level preferred) in bioengineering, biochemistry, biotechnology or a related field.

What you'll love about working here

Own your Growth: 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. Our engineering academy offers more than 60,000 hours of training to support your professional development.

Connect for Success: Our professional communities foster career development and strengthen Capgemini's capabilities across various domains. You will also benefit from mentoring programs to stimulate your professional growth.

Lead the Change: As a global leader in engineering services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies to help our clients develop the smart products and services of tomorrow.

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.