MSAT Process Engineer
Il y a 3 heures
Antwerp, Flanders, Belgique
Pauwels Consulting
Temps plein
Gratuit avec email ou Google
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Gratuit avec email ou Google
Our client, a leading pharmaceutical organization, is seeking a professional to provide commercial manufacturing support and process optimization. The role focuses on technology transfer activities to facilitate the introduction of new products and processes within a large-scale manufacturing environment.
Support the technology transfer of drug substance manufacturing processes from development laboratories to large-scale GMP facilities.
Ensure documentation readiness by conducting process fit-gap analyses, defining control strategies, and preparing sampling plans.
Lead process improvement initiatives to increase yield or robustness and generate data packages to enable implementation.
Provide ongoing support for commercial manufacturing processes through data trending, monitoring, and the development of technical study protocols.
Contribute to investigations and process impact assessments for significant manufacturing deviations.
Master’s or PhD degree in Life Sciences.
You have 5+ years (Master’s) or 3+ years (PhD) of experience in process development or MSAT-related roles.
You bring hands-on experience with mammalian cell culture or purification processes at laboratory or manufacturing scale.
You possess a solid understanding of GMP principles and process control strategies.
You're a detail-oriented professional with strong analytical skills and the ability to adapt to shifting priorities in a fast-paced environment.
You are fluent in English.
Nice to HavesExperience with statistical and data trending tools such as JMP, Statistica, Matlab, or Simca.
Prior experience working within a GMP environment.
Support the technology transfer of drug substance manufacturing processes from development laboratories to large-scale GMP facilities.
Ensure documentation readiness by conducting process fit-gap analyses, defining control strategies, and preparing sampling plans.
Lead process improvement initiatives to increase yield or robustness and generate data packages to enable implementation.
Provide ongoing support for commercial manufacturing processes through data trending, monitoring, and the development of technical study protocols.
Contribute to investigations and process impact assessments for significant manufacturing deviations.
Master’s or PhD degree in Life Sciences.
You have 5+ years (Master’s) or 3+ years (PhD) of experience in process development or MSAT-related roles.
You bring hands-on experience with mammalian cell culture or purification processes at laboratory or manufacturing scale.
You possess a solid understanding of GMP principles and process control strategies.
You're a detail-oriented professional with strong analytical skills and the ability to adapt to shifting priorities in a fast-paced environment.
You are fluent in English.
Nice to HavesExperience with statistical and data trending tools such as JMP, Statistica, Matlab, or Simca.
Prior experience working within a GMP environment.