Qualification & Validation Engineer – Packaging, Medical Devices & Sterilization
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Expérience:
Minimum 3 ans 🌍 Langues : Français courant – Anglais technique 🎯 Contexte de la mission Dans le cadre du renforcement de ses activités de Qualification & Validation, notre client recherche un Q&V Engineer pour intervenir sur des projets liés aux équipements de packaging, d'assemblage de dispositifs médicaux et de stérilisation. ⚙️ Vos responsabilités Vous serez en charge de la qualification IQ/OQ/PQ des équipements de production, packaging et assemblage de dispositifs médicaux, notamment des lignes de conditionnement primaire et secondaire (sealing, labelling, blistering, cartoning, etc.). Vous interviendrez également sur la qualification des équipements et procédés d'assemblage de Medical Devices et Combination Products, ainsi que sur les activités de qualification et validation liées aux procédés de stérilisation (Steam, EtO, Gamma). Vos missions comprendront la rédaction et l'exécution des protocoles, les revues périodiques de qualification, la gestion des déviations et Change Controls, ainsi que la collaboration avec les équipes Engineering, Manufacturing et Quality. 👤
Votre profil
Vous disposez d'au moins 3 ans d'expérience en Qualification & Validation dans un environnement pharmaceutique ou Medical Devices, avec une solide expérience terrain sur des équipements industriels, idéalement en packaging et assemblage de dispositifs médicaux. Vous maîtrisez les méthodologies IQ/OQ/PQ et les exigences GMP. Une expérience en stérilisation, en packaging de dispositifs médicaux stériles constitue un réel atout. Autonome, proactif et orienté solutions, vous appréciez le travail sur le terrain et les environnements techniques exigeants. 📩 Intéressé(e) par cette opportunité ? Contactez-nous pour en discuter
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