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Open nowFirst seen 3 days ago

Equipment Engineer Commissioning & Qualification Pharma (Employed or freelance)

EngiFlex113 open roles

Where
Beerse, Belgium
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Your applicationOpen nowEquipment Engineer Commissioning & Qualification Pharma (Employed or freelance)EngiFlex · 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.

12.1% 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. 12.1%7 days
  4. 19.1%14 days
  5. 35.6%30 days
  6. 52.7%60 days
This job: first seen 3 days ago

EngiFlex median: 2 days open

The posting

Functieomschrijving

Als Commissioning & Qualification Equipment Engineer ben je verantwoordelijk voor het opstellen, onderhouden en uitvoeren van kwalificatiedocumentatie voor GMP-kritische apparatuur, utilities en systemen. Je zorgt ervoor dat alle documentatie voldoet aan de geldende GMP-vereisten en interne kwaliteitsnormen.

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

📌 Fortunately, we can count on you for:

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

📝 Jouw profiel

Je werkt gestructureerd, hebt oog voor kwaliteit en voelt je thuis in een GMP-omgeving. Je stemt vlot af met verschillende stakeholders en werkt graag samen in teamverband. Tegelijk kan je documentatie- en kwalificatieactiviteiten zelfstandig opnemen.

  • Een bachelor- of masterdiploma in een wetenschappelijke of technische richting, zoals industriële ingenieurswetenschappen, biochemie, biotechnologie of farmaceutische wetenschappen
  • Een sterke interesse in de farmaceutische sector en gereguleerde GMP-omgevingen
  • Sterke vaardigheden in technisch schrijven en documentbeheer
  • Ervaring met engineering systems, utilities of productieapparatuur is een plus
  • Een vlotte kennis van Nederlands en Engels, mondeling en 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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