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Open nowPosted 8 days ago

Project Engineer Formulatie

Enginity

Where
Mechelen, Belgium
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Your applicationOpen nowProject Engineer FormulatieEnginity · Mechelen, Belgium

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The clock on this job

Early applications get read.

12.7% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.7%7 days
  4. 20.4%14 days
  5. 35.6%30 days
  6. 58.7%60 days
This job: posted 8 days ago

The posting

Als Project Engineer Formulatie neem je een sleutelrol op binnen een technisch project bij een farmaceutische klant in Puurs. Je focust op aseptische formulatieprocessen en procesinstallaties en combineert technische expertise met projectcoördinatie, verificatie en validatie.Engineering en technische projectuitwerking

  • Werk aan procestechnologie zoals CIP/SIP-systemen, isolatortechnologie, utiliteitspanelen, mengers, tankkoeling en mobiele RVS-vaten.
  • Lever technische, operationele en compliancegerichte input aan het projectteam.
  • Definieer en documenteer technische specificaties, Engineering Design Specifications, P&ID's en elektrische schema's.
  • Bewaak dat ontwerpkeuzes voldoen aan normen, projectdoelstellingen en farmaceutische vereisten.
  • Volg installaties technisch op en stuur leveranciers aan tijdens bouw, installatie en testing.

Projectcoördinatie, validatie en overdracht

  • Volg planning, budget, rapportering, besluitvorming en stakeholders op.
  • Definieer en voer engineeringtesten, verificatie en validatie uit.
  • Stel testprotocollen en verificatie- en validatiedocumentatie op.
  • Werk nauw samen met Subject Matter Experts en andere betrokken partijen.
  • Ondersteun de overdracht naar productie en volg opstartresultaten en afwijkingen op.
  • Beheer acties via CAPA's, risicoanalyses en CGMP-beoordelingen.
  • Je hebt een masterdiploma in engineering of een gelijkwaardig technisch niveau door ervaring.
  • Je hebt ervaring met het uitvoeren, plannen en coördineren van CAPEX-projecten.
  • Je hebt technische affiniteit met aseptische formulatieprocessen en installaties zoals CIP/SIP-systemen, mengers, tanks, RVS-vaten en utilities.
  • Je hebt een goede kennis van Nederlands en Engels.
  • Ervaring binnen farma en kennis van GMP, risicoanalyses, verificatie en validatie zijn sterke troeven.
  • Je communiceert helder, neemt initiatief en werkt pragmatisch en resultaatgericht.
  • Je werkt zelfstandig, hands-on en kwaliteitsgedreven en weet een projectteam mee te krijgen.

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