Upstream Process Engineer: Gene Therapy GMP Specialist

Capgemini Engineering; Diegem; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Capgemini Engineering is seeking an Upstream Process Engineer to support the readiness of a gene therapy manufacturing facility. You will act as SME during equipment validation and SAT activities, author GMP documents, and collaborate across cross-functional teams in French and English.

The role requires 2+ years in upstream bioprocessing, GMP documentation experience, and a science/engineering degree. Strong communication and an autonomous, proactive mindset are essential.

Qualifications

• Minimum 2 years of upstream bioprocessing experience (cell culture, development, operations, and equipment)
• Exposure to viral vector or gene therapy manufacturing (e.g. AAV) is a plus
• GMP documentation proficiency including authoring procedures, process descriptions and risk assessments
• Full professional fluency in both French and English (spoken and written)
• Strong interpersonal and organizational skills for multi-priority environments

Responsabilités

• Serve as SME for upstream process during equipment validation and SAT activities, translating requirements into qualification protocols
• Author and review GMP documentation including SOPs, process descriptions, risks, and batch docs in French and English
• Contribute to GMP and campaign readiness activities and mock runs in collaboration with cross-functional teams
• Collaborate closely with operators, validation engineers, process experts, and project stakeholders across French- and English-speaking environments
• Support strategic process and operational decisions and contribute to campaign setup and facility readiness

Connaissances

Upstream bioprocessing

GMP documentation

Bilingual French/English

Cross-functional collaboration

Formation

Engineering or Master’s in bioengineering/biochemistry/biotechnology

Outils

SAT/IQ/OQ

Description du poste

Capgemini Engineering is seeking an Upstream Process Engineer to support the readiness of a gene therapy manufacturing facility. You will act as SME during equipment validation and SAT activities, author GMP documents, and collaborate across cross-functional teams in French and English.

The role requires 2+ years in upstream bioprocessing, GMP documentation experience, and a science/engineering degree. Strong communication and an autonomous, proactive mindset are essential.