Over het bedrijf
Een internationale farmaceutische organisatie die innovatieve geneesmiddelen ontwikkelt binnen een sterk gereguleerde GMP-productieomgeving.
Functieomschrijving
Als Maintenance Engineer ondersteun je de Business System Owner bij het beheer van farmaceutische watersystemen, waaronder WFI/WDI, BMS en EMS. Je zorgt voor de betrouwbaarheid van installaties, GMP-compliance en operationele gereedheid en draagt bij aan onderhoudsstrategieën, investeringsplannen en technische projecten.
Belangrijkste verantwoordelijkheden
- Beheren van clean utility-assets om betrouwbaarheid, beschikbaarheid, kwaliteit en kostenefficiëntie te waarborgen
- Ondersteunen van langetermijnonderhoudsstrategieën en CAPEX-investeringsplannen
- Beoordelen en beheren van wijzigingen (MoC) tijdens ontwerp, commissioning en kwalificatie
- Beoordelen van technische gegevens en de impact van voorgestelde wijzigingen
- Ondersteunen van engineeringprojecten en zorgen voor een goede overdracht en operationele gereedheid
- Bewaken van naleving van GMP-, EHS- en interne assetmanagementvereisten
- Identificeren en implementeren van verbeteringen aan clean utility-systemen
- Samenwerken met de Business System Owner en de Maintenance- en Engineeringteams
Vereisten
- Minimaal 2 jaar ervaring binnen een farmaceutische/GMP-omgeving
- Praktische ervaring met WFI/WDI-clean utility-systemen — must-have
- Ervaring met assetmanagement en onderhoud van farmaceutische utilities
- Kennis van BMS en besturingssystemen voor clean utilities
- Kunnen lezen en aanpassen van P&ID's
- Kennis van GMP, Management of Change, commissioning en kwalificatie
- Goede communicatieve vaardigheden in het Engels & Nederlands
- Ervaring met SAP PM of andere CMMS-systemen is een pré
- Ervaring met CAPEX-planning en investeringsprojecten is een voordeel
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