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Open nowPosted 15 hours ago

Sterilization Validation Engineer | Pharma | Puurs

SELECT PROJECTS (Select)

Where
Mechelen, Belgium
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Your applicationOpen nowSterilization Validation Engineer | Pharma | PuursSELECT PROJECTS (Select) · Mechelen, Belgium

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Share of postings closed within
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  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: posted 15 hours ago

The posting

Jouw baan als Sterilization Validation Engineer

Ben je geboeid door sterilisatieprocessen, technologie en kwaliteit binnen een GMP-omgeving? Als Sterilization Validation Engineer werk je mee aan projecten rond nieuwe installaties, proceswijzigingen en herkwalificaties binnen een farmaceutische productieomgeving. Je zorgt ervoor dat sterilisatieprocessen correct gevalideerd worden en voldoen aan alle kwaliteits- en regelgevingseisen. Daarbij werk je nauw samen met projectteams, productie en kwaliteitsafdelingen. Dankzij jouw nauwkeurige aanpak draag je rechtstreeks bij aan veilige geneesmiddelen voor patiënten wereldwijd.

Gelukkig kunnen we op jou rekenen bij het:

  • Opstellen van testprotocollen en validatierapporten voor sterilisatieprojecten
  • Definiëren van de juiste sterilisatiestrategie volgens GMP-richtlijnen
  • Plannen, coördineren en opvolgen van validatie- en kwalificatietesten
  • Onderzoeken van afwijkingen en bepalen van corrigerende acties
  • Updaten van GMP-documentatie na succesvolle studies
  • Afstemmen van planning, voortgang en resultaten met projectteams
  • Meewerken aan optimalisatie- en verbeterprojecten binnen validatieprocessen

Je werkt gestructureerd en nauwkeurig, ook wanneer verschillende projecten gelijktijdig lopen. Daarnaast communiceer je vlot met collega's uit diverse afdelingen en ga je probleemoplossend te werk bij technische of kwaliteitsgerelateerde uitdagingen. Je draagt graag bij aan een gezamenlijke doelstelling en voelt je goed binnen een teamomgeving.

Hard skills

  • Bachelor of Master in Bio-ingenieurswetenschappen, Industriële Ingenieurswetenschappen, Farmaceutische Wetenschappen of gelijkwaardige ervaring
  • Minstens 2 jaar ervaring binnen validatie, engineering of GMP
  • Ervaring binnen een farmaceutische of sterk gereguleerde omgeving
  • Uitstekende kennis van Nederlands en Engels
  • Bereidheid om in een tweeploegenstelsel te werken (06u-14u en 14u-22u)

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