Upstream Bioprocess Engineer – GMP & 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

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