Validation Engineer
vor 3 Monaten
Vos missions incluront :
Validation des Systèmes d'Assemblage :
- Assumer la validation de nos systèmes d’assemblage conformément aux objectifs convenus avec nos partenaires (délais, qualité).
- Identifier les problèmes techniques, rechercher des solutions et les communiquer aux équipes de projet.
Communication et Coordination :
- Servir de point de contact central entre les partenaires et l’équipe de projet interne pour tous les sujets relatifs à la qualification/validation des systèmes d’assemblage.
Documentation :
- Réaliser et maintenir la documentation de qualification/validation dès la phase de design des projets, couvrant les aspects mécaniques, logiciels et matériels.
Gestion des Activités de Qualification/Validation :
- Diriger les activités de qualification/validation des projets, incluant :
- Analyses de risques
- Rédaction des protocoles
- Exécution des tests durant les FAT (Factory Acceptance Tests) et SAT (Site Acceptance Tests)
- Environ 20% du temps de travail sera consacré à des déplacements chez nos partenaires.
- Diriger les activités de qualification/validation des projets, incluant :
Formation :
- Diplôme en ingénierie mécanique ou équivalent.
Expérience :
- Expérience en qualification/validation de systèmes automatisés couvrant les aspects mécanique, logiciel et matériel.
- Expérience confirmée en validation de processus mécanique.
- Une expérience dans l’industrie pharmaceutique ou médicale serait un atout.
Connaissances Techniques :
- Connaissance des directives et des normes applicables.
Compétences Linguistiques :
- Très bonnes connaissances du français.
- Bonnes connaissances de l’anglais (niveau B2) et/ou de l’allemand.
Compétences Personnelles :
- Esprit d’analyse et de synthèse.
- Capacité à fixer des objectifs clairs et à gérer les priorités.
- Disponibilité et motivation pour relever des défis.
- Intérêt pour l'innovation et les technologies d’automatisation.
- Agilité, flexibilité et adaptabilité.
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