Senior Process Engineer
3 weken geleden
Bent u een expert in geautomatiseerde productieprocessen en technologieoverdracht?
Functiebeschrijving:
Als Senior Process Engineer bij onze klant in de farmaceutische sector speelt u een sleutelrol in de ondersteuning van de wereldwijde implementatie en optimalisatie van geautomatiseerde processen voor de productie van CAR-T celtherapieën. U bent verantwoordelijk voor het ontwikkelen van procedures die de overgang van het klinische naar het commerciële productieproces vergemakkelijken.
Verantwoordelijkheden:
- Fungeren als specialist voor geautomatiseerde productieprocessen en technologieoverdracht
- Opstellen van plannen voor procesontwerp, proceskwalificatie en procesvalidatie
- Leiding geven aan product- en procesgerelateerde veranderingen binnen het wereldwijde netwerk
- Uitvoeren van onderzoeken naar product- en procesafwijkingen, en implementeren van corrigerende maatregelen
- Opstellen van procesdocumentatie, SOP's en trainingsmaterialen voor het productienetwerk
- Ondersteuning bieden bij de ontwikkeling van elektronische batchrecords en procedures
- Bijdragen aan de ontwikkeling van real-time proces- en productmonitoring en het beheer van apparatuur
Profiel:
- MSc of PhD in Life Sciences, Biotechnologie of Engineering
- Minimaal 7 jaar ervaring in een soortgelijke functie binnen de farmaceutische of biotechnologische sector
- Ervaring met procesvalidatie, technologieoverdracht en geautomatiseerde productieprocessen
- Vloeiend in Engels
- Flexibiliteit en het vermogen om te schakelen tussen verschillende prioriteiten
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