Biotech Industry Optimization Specialist New
il y a 2 semaines
Location:
Puurs, Belgium
- Contact:
Dardo Helpers
- Job type:
Contract
- Contact phone:
+32 15 44 58 52
- Industry:
Pharmaceutical
Als Project Manager van slag met ervaring in implementatie van nieuwe productie methodes binnen een GMP omgeving. Je werkt jouw projecten uit van aankoop installaties tot finale kwalificatie.
**Job omschrijving**
Als Project Consultant breng je een cruciale bijdrage aan het Predictive Plant Acceleration programma, een aanzienlijk kapitaalinvesteringsinitiatief gericht op het invoeren en implementeren van gloednieuwe tools voor de farmaceutische Manufacturing Site. Als de tactische en technische projectleider speelt u een cruciale rol in de ondersteuning van de aankoop-, kwalificatie
- en algoritmeontwikkelingsfasen van het project.
**Verantwoordelijkheden**
- Samenwerken met cross-functionele teams om User Requirement Specifications (URS) en Functional Design Specifications (FDS) voor apparatuur en instrumenten te definiëren.
- Beheren van het inkoopproces, inclusief leveranciersinterface en het verkrijgen van offertes voor vereiste technologieën.
- Zorg voor technisch leiderschap tijdens het kwalificatieproces (installatiekwalificatie, operationele kwalificatie, prestatiekwalificatie - IQOQ).
- Bijdragen aan de ontwikkeling en validatie van algoritmen tijdens de initiële installatiefase.
- Ondersteunen van de inzet van geavanceerde technologieën, inclusief maar niet beperkt tot:
Snelle reinigingsverificatiemethoden met behulp van Ion Mobility Spectroscopy (IMS).
- Aanschaf en inzet van slimme sensoren (temperatuur & flow) voor productie-in-proces testen.
- Inzet van at-line eiwit/DS-concentratiemethoden/-algoritmen tijdens de bereidingsfase (UV-gebaseerde methoden of alternatieven).
**Profiel**
- Diepgaande kennis van cGMP-vereisten en regelgevende normen die van toepassing zijn op de farmaceutische industrie.
- Aantoonbare ervaring met apparatuurkwalificatie en bijbehorende documentatie.
- Sterke achtergrond in analytische methodevalidatie en bijbehorende documentatie.
- Vaardigheid in Data Science tools zoals Python, MatLab, Spotfire en andere relevante platforms.
- Expertise in robotwetenschappen en bekendheid met automatiseringstechnologieën.
- Eerdere betrokkenheid bij de productie van biofarmaceutische geneesmiddelen.
- Uitstekende communicatieve vaardigheden in het Engels, met het vermogen om effectief te communiceren in een multiculturele omgeving.
**Benefits**
- Direct in dienst bij Oxford, initieel project tot juli 2025 (freelance bespreekbaar);
- Mobiele telefoon verstrekt & maandelijkse telefoon bijdrage;
- Maandelijkse maaltijd vergoeding;
- Reiskostenvergoeding;
- Ziekenhuis
- en groepsverzekering;
- Mogelijkheden voor onderwijs en opleiding;
- Fulltime functie, overdag werken;
- Regio: Puurs
Vacature nummer: 23365
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