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Open nowPosted 13 hours ago

Cleaning Validation Engineer

USG Professionals

Where
Antwerpen, Belgium
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Your applicationOpen nowCleaning Validation EngineerUSG Professionals · Antwerpen, Belgium
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  5. 36.6%30 days
  6. 58.9%60 days
This job: posted 13 hours ago

The posting

Onze klant is een van de grootste farmaceutische bedrijven ter wereld. De site in regio Antwerpen is de grootste productie- en verpakkingssite in Europa.

Jobomschrijving

Jouw uitdaging

Als Cleaning Validation Analyst ben je verantwoordelijk voor de planning, uitvoering en rapportering van studies en testen rond cleaning validation en risicobeoordelingen.

Je ondersteunt zowel operationele teams als projectteams bij verschillende cleaning validation-initiatieven. Daarbij combineer je praktische werkzaamheden met analytische taken en technische rapportering.

Je verantwoordelijkheden omvatten onder andere:

  • Je stelt protocollen en rapporten op voor cleaning validation-studies en risicobeoordelingen.
  • Je plant en voert routinematige reinigingskwalificatiestudies uit.
  • Je analyseert de resultaten van uitgevoerde testen en studies.
  • Je ondersteunt de opvolging van bestaande geneesmiddelen door cleaning validation-activiteiten voor geplande product- en proceswijzigingen praktisch voor te bereiden, uit te voeren en te rapporteren.
  • Je draagt bij aan lifecycle management en het onderzoek naar kwaliteitsproblemen.
  • Je ondersteunt de proactieve monitoring van productkwaliteit door de effectiviteit en conformiteit van reinigingsprocessen mee op te volgen.

Wie zoeken we?

Voor deze functie zoeken we iemand met een technische of wetenschappelijke achtergrond en sterke organisatorische en analytische vaardigheden.

Daarnaast beschik je over volgende kwaliteiten en competenties:

  • Je hebt een bachelor in industriële, burgerlijke of bio-ingenieurswetenschappen, industriële farmacie of gelijkwaardig door ervaring.
  • Je beschikt over goede sociale en communicatieve vaardigheden en werkt graag samen met anderen.
  • Je kunt vlot overweg met courante pc-softwaretoepassingen.
  • Je beheerst zowel het Nederlands als het Engels uitstekend.
  • Je beschikt over een goede technische schrijfstijl.
  • Je bent analytisch en probleemoplossend ingesteld en kunt creatief meedenken bij afwijkingen en mogelijke verbeteringen.
  • Je werkt georganiseerd en nauwkeurig.
  • Je bent bereid om in een tweeploegenstelsel te werken: vroege ploeg: 6u – 14u en late ploeg: 14u – 22u.
  • Ervaring met gelijkaardige projecten en kennis van of ervaring binnen een GMP omgeving zijn een pluspunt.

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