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Open nowPosted 80 days ago

Lead Commissioning & Qualification Engineer Beerse

EURES job mobility portal222,662 open roles

Where
Turnhout, Belgium
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Your applicationOpen nowLead Commissioning & Qualification Engineer BeerseEURES job mobility portal · Turnhout, Belgium

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  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

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The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 80 days ago

The posting

Voor diverse projecten binnen een aseptische productieomgeving zijn wij op zoek naar een Commissioning & Qualification Engineer.

In deze rol combineer je hands-on technische expertise met leiderschapsvaardigheden. Je coördineert kwalificatie-activiteiten, begeleidt een klein team in het veld en zorgt ervoor dat projecten tijdig en volledig compliant worden opgeleverd.

Jouw rol

Als Commissioning & Qualification Engineer ben je dé technische specialist binnen multidisciplinaire projectteams. Je werkt nauw samen met Operations, Engineering, QA en Validation en bent verantwoordelijk voor het kwalificeren van apparatuur, processen en softwaresystemen gedurende hun volledige lifecycle, van commissioning tot prestatievalidatie.

Verantwoordelijkheden

  • Uitvoeren en coördineren van commissioning- en kwalificatieprotocollen ( IQ, OQ, PQ) voor procesequipment, systemen en software.
  • Fungeren als C&Q-specialist binnen projectteams, adviseren over technische en GMP-compliance aspecten.
  • Opstellen, reviewen en goedkeuren van documentatie, waaronder: User Requirements Specifications (URS) Design Qualification (DQ) Risicobeoordelingen (FMEA) IQ/OQ/PQ-protocollen en test scripts Samenvattende rapporten en opleverdocumentatie
  • Leiding geven aan een klein team tijdens veldwerk, zoals P&ID-controles, functionele testen en FAT/SAT.
  • Beheren van afwijkingen, change controls en CAPA’s in lijn met GMP-vereisten.
  • Waarborgen van GMP/GDP-compliance en data integrity in alle projectactiviteiten.
  • Ondersteunen van kleinere projecten, zoals non-conformities, upgrades of like-for-like vervangingen van equipment.
  • Bio-ingenieur of Ingenieur Elektromechanica, Chemie, Biochemie, ... of Master Biomedische wetenschappen, Biotechnologie, ...
  • Minstens 2 jaar relevante werkervaring
  • kennis GMP/GDP
  • Communicatief en organisatorisch sterk
  • Vloeiende communicatie Nederlands aangevuld met een goede kennis Engels
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