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Open nowPosted 7 days ago

Validation Engineer

NOVA Engineering nv

Where
Turnhout, Belgium
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Your applicationOpen nowValidation EngineerNOVA Engineering nv · Turnhout, Belgium
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The clock on this job

Early applications get read.

13.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.6%3 days
  3. 13.3%7 days
  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: posted 7 days ago

The posting

Voor een internationale speler binnen een sterk gereguleerde productieomgeving zijn we op zoek naar een ervaren Validation Engineer die verantwoordelijk is voor de kwalificatie en validatie van equipment, cleanrooms, HVAC-systemen, faciliteiten en utilities.

De komende jaren staan er verschillende investerings- en uitbreidingsprojecten op de planning, waarbij een aanzienlijk aantal nieuwe installaties en productielijnen zal worden geïmplementeerd. De eerste focus ligt op compounding-installaties, maar daarnaast zullen ook diverse filling- en assembly-equipmentprojecten deel uitmaken van het takenpakket.

In deze rol ben je verantwoordelijk voor het volledige validatietraject, van risicoanalyse en teststrategie tot uitvoering, rapportering en vrijgave. Je werkt nauw samen met engineering, productie, kwaliteit, onderhoud en externe leveranciers om ervoor te zorgen dat alle systemen voldoen aan de geldende GMP-richtlijnen en kwaliteitsvereisten.

Jouw taken bestaan onder andere uit:

  • Opstellen en uitvoeren van kwalificatie- en validatieplannen voor equipment, cleanrooms, HVAC-systemen en utilities.
  • Uitwerken van DQ-, IQ-, OQ- en PQ-protocollen en rapporten.
  • Begeleiden van FAT- en SAT-testen bij leveranciers en op site.
  • Uitvoeren van risicoanalyses en impactanalyses binnen wijzigingsprojecten.
  • Ondersteunen van commissioning- en opstartactiviteiten van nieuwe installaties.
  • Behandelen van afwijkingen, CAPA's, change controls en rekwalificaties.
  • Samenwerken met verschillende interne stakeholders en externe partners gedurende de volledige projectlevenscyclus.
  • Bewaken van GMP-compliance en inspectierijp houden van validatiedocumentatie.
  • Bachelor of Master in een technische of wetenschappelijke richting.
  • Ervaring binnen een GMP-gereguleerde omgeving zoals farmaceutische, biotech-, medische of voedingsindustrie.
  • Kennis van kwalificatie- en validatieprocessen voor equipment, facilities en utilities.
  • Ervaring met cleanroomvalidatie en HVAC-systemen is een sterke troef.
  • Goede kennis van GMP, GDP, risicobeheer en validatielifecycles.
  • Ervaring met FAT, SAT, commissioning en opstart van nieuwe installaties.
  • Sterke communicatieve vaardigheden en het vermogen om verschillende stakeholders samen te brengen.
  • Analytische, gestructureerde en kwaliteitsgerichte aanpak.
  • Goede kennis van Nederlands en Engels.

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