Maintenance Engineer

Maintenance Engineer voor farmaceutische watersystemen (WFI/WDI, BMS/EMS) bij SIRE Life Sciences, locatie Leiden, tijdelijke opdracht.

Locatie
Leiden
Sluitingsdatum

Geen duidelijke warme-stoelaanwijzingen in de beschikbare beoordeling.

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Alle 2 publicaties en brokers

Eisen

  • Goede communicatieve vaardigheden in het Engels & Nederlands
  • Ervaring met assetmanagement en onderhoud van farmaceutische utilities
  • Minimaal 2 jaar ervaring binnen een farmaceutische/GMP-omgeving
  • Kennis van GMP, Management of Change, commissioning en kwalificatie
  • Kennis van BMS en besturingssystemen voor clean utilities
  • Kunnen lezen en aanpassen van P&ID's
  • Praktische ervaring met WFI/WDI-clean utility-systemen

Wensen

  • Ervaring met CAPEX-planning en investeringsprojecten
  • Ervaring met SAP PM of andere CMMS-systemen
Volledige omschrijving

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

59245

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