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Open nowPosted 58 days ago

Project engineer Validation

EURES job mobility portal178,122 open roles

Where
Maaseik, Belgium
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Your applicationOpen nowProject engineer ValidationEURES job mobility portal · Maaseik, 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 EURES job mobility portal's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

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 58 days ago

The posting

Het doel van de functie is om de validatie van systemen, processen, installaties en apparatuur binnen de organisatie op het gewenste niveau te brengen en te houden. Daarbij dienen de wettelijke kaders en in het bijzonder de farmaceutische richtlijnen en regelgeving in acht te worden genomen, en dient deels in overleg met de kwaliteitsverantwoordelijken van klanten een strategie te worden bepaald.

  • Het uitvoeren van interne audits en het begeleiden van externe audits (interne, klanten, notified bodies) in het kader van validatie.
  • Het (laten) opzetten, implementeren en borgen van validatie studies, in overleg met medewerkers van Operations, Supply Chain, Technische Dienst en QA .
  • Het (laten) documenteren van alle validatieactiviteiten en validatieresultaten
  • Het leveren van een bijdrage aan de verbetering en optimalisatie van personeel, processen en systemen en uitgevoerde procedures.
  • Het opstellen van procedures ten aanzien van de validatie activiteiten
  • Het beoordelen van de benodigde validatie naar aanleiding van (voorgestelde) wijzigingen in systemen, processen, installaties of apparatuur
  • De validatie van systemen, processen, installaties en apparatuur tijdig in gang wordt gezet en doorgevoerd.
  • De uitgevoerde validatie activiteiten van een goed niveau zijn en voldoen aan de vigerende internationale wet- en regelgeving op het gebied van validatie en GMP.
  • Doorgevoerde wijzigingen niet van invloed zijn op de validatie-status van systemen, processen, installaties en apparatuur.
  • Bachelor of Master Industriële wetenschappen
  • Enkele jaren ervaring binnen een farmaceutische productieomgeving is een pluspunt
  • Bekend en vertrouwd met GMP-richtlijnen, farmaceutische richtlijnen, kennis van microbiologie, hygiëne, e.d.
  • Ervaring met kwaliteitssystemen, procedures, trainingen, e.d.
  • Kan werken met MS-office
  • Goede kennis van het Engels (geschreven en gesproken)
  • Ervaring in het schrijven van rapporten
  • Gedreven persoonlijkheid
  • Eigenaarschap (verantwoordelijkheidszin)
  • Kan zowel zelfstandig werkzaamheden organiseren en hierbij de juiste prioriteiten stellen als in team werken.
  • Doelbewust
  • Analytisch en “open minded” denkvermogen
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    The review screen in CV Rocket: how each CV was read, round by round.

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