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Open nowFirst seen 47 hours ago

Commissioning & Qualification Engineer voor Farma Equipment

EngiFlex115 open roles

Where
Beerse, Belgium
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Your applicationOpen nowCommissioning & Qualification Engineer voor Farma EquipmentEngiFlex · Beerse, Belgium

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

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

  4. CV RocketApplied on EngiFlex's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. EngiFlex postings stay open a median of 2 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: first seen 47 hours ago

EngiFlex median: 2 days open

The posting

Functieomschrijving

Als Commissioning & Qualification Equipment Engineer ben je verantwoordelijk voor het opstellen, beheren en uitvoeren van kwalificatiedocumentatie voor GMP-kritische equipment, utilities en systemen. Je zorgt ervoor dat alle documenten voldoen aan de geldende GMP-richtlijnen en interne kwaliteitsstandaarden.

Je werkt nauw samen met C&Q Leads, Subject Matter Experts en projectteams om kwalificatietrajecten van opstart tot afronding te ondersteunen. Naast documentatie neem je ook deel aan testactiviteiten en de verdere opvolging ervan. Zo help je systemen in een gevalideerde en conforme toestand te houden.

📌 Fortunately, we can count on you for:

  • Opstellen van kwalificatiedocumentatie zoals URS, SRS, IA, DQ, IQ, OQ, PQ, QSR en Validation Master Plans
  • Uitvoeren en documenteren van kwalificatietesten voor equipment, utilities en systemen
  • Beoordelen van de impact van wijzigingen, afwijkingen en discrepanties op kwalificatieactiviteiten
  • Coördineren van documentreviews, goedkeuringsflows en handtekeningprocessen
  • Opvolgen van punch list-items en kwalificatieacties tot afsluiting
  • Ondersteunen van interne en externe audits en inspecties
  • Beheren van documentarchivering volgens GMP- en GDP-vereisten

📝 Jouw profiel

Je werkt gestructureerd, kwaliteitsgericht en voelt je thuis in een GMP-omgeving. Je schakelt vlot met verschillende stakeholders, functioneert goed in teamverband en kan tegelijk zelfstandig documentatie- en kwalificatieactiviteiten opnemen.

  • Je behaalde een bachelor- of masterdiploma in een wetenschappelijke of technische richting, zoals industriële ingenieurswetenschappen, biochemie, biotechnologie of farmaceutische wetenschappen
  • Je hebt een sterke interesse in de farmaceutische sector en in GMP-gereguleerde omgevingen
  • Je beschikt over sterke vaardigheden in technical writing en documentatie
  • Ervaring met engineeringsystemen, utilities of productieapparatuur is een plus
  • Je communiceert vloeiend in Nederlands en Engels, zowel mondeling als schriftelijk

💼 Aanbod

Je zal deel uitmaken van een groeiende KMO met ruimte voor initiatief en persoonlijke ontwikkeling. Wij zorgen ervoor dat je in een uitdagende maar aangename werkomgeving terecht komt met leuke collega's. Samen met jou stippelen we een carriereplan uit, met aandacht en budget voor bijkomende opleidingingen / certificaties. Je kan rekenen op een motiverend salaris, aangevuld met extralegale voordelen, inclusief bedrijfswagen (of alternatieve vergoeding). (Freelance is ook mogelijk)

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