MSAT Process Engineer—Cell Culture & Purification

Pauwels Consulting; Geel; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a professional to support commercial manufacturing and process optimization within a large-scale GMP environment. The role centers on technology transfer to enable the introduction of new products and processes, with emphasis on documentation readiness and data-driven decision making.

You will lead process improvements, develop study protocols, and provide ongoing support for manufacturing through data trending and monitoring. Fluency in English is required.

Qualifications

• Master’s or PhD in Life Sciences.
• 5+ years (Master’s) or 3+ years (PhD) in process development or MSAT-related roles.
• Hands-on experience with mammalian cell culture or purification processes at laboratory or manufacturing scale.
• Solid understanding of GMP principles and process control strategies.
• Detail-oriented with strong analytical skills and ability to adapt to shifting priorities in a fast-paced environment.
• Fluent in English.

Responsabilités

• Support technology transfer of drug substance manufacturing processes from development to GMP facilities.
• Ensure documentation readiness by conducting fit-gap analyses, defining control strategies, and preparing sampling plans.
• Lead process improvement initiatives to increase yield or robustness and generate data packages for implementation.
• Provide ongoing support for commercial manufacturing through data trending, monitoring, and development of technical study protocols.
• Contribute to investigations and process impact assessments for significant manufacturing deviations.

Connaissances

Mammalian cell culture

Purification processes

GMP principles

Process development

MSAT

Data trending

English

Formation

Master’s degree in Life Sciences

PhD in Life Sciences

Outils

JMP

Statistica

Matlab

Simca

Description du poste

Pauwels Consulting is seeking a professional to support commercial manufacturing and process optimization within a large-scale GMP environment. The role centers on technology transfer to enable the introduction of new products and processes, with emphasis on documentation readiness and data-driven decision making.

You will lead process improvements, develop study protocols, and provide ongoing support for manufacturing through data trending and monitoring. Fluency in English is required.