Project Engineer Fill&Finish

vor 1 Woche

Neuenburg, Neuenburg, Schweiz Kelly Services Switzerland Vollzeit
Pour notre partenaire situé dans le canton de Neuchâtel, Kelly Life Sciences recherche un(e) : Ingénieur(e) projets

Date de début : ASAP

Date de fin : 30/09/2024

Votre mission :

En tant qu'Ingénieur de Projet, vous fournissez une expertise en ingénierie pour le projet d'extension de la nouvelle usine, de la planification et de l'exécution du projet jusqu'aux phases de reporting. Vous soutenez la livraison du projet en interaction avec l'équipe de projet interne, les entrepreneurs et les fabricants d'équipement.

Vos tâches :

Sous la responsabilité du chef de projet :

- Vous êtes le premier contact en ce qui concerne les aspects techniques.

- Vous contribuez à définir le calendrier du projet, y compris les temps d'arrêt nécessaires.

- Vous gérez une communication claire entre les parties prenantes afin d'atteindre les objectifs et de maintenir le calendrier du projet.

- Vous dirigez l'analyse des risques du projet afin d'aider la direction à prendre des décisions.

- Vous identifiez les aspects financiers des modifications éventuelles.

- Vous proposez des actions correctives ou des améliorations.

- Vous définissez les documents de qualification en collaboration avec les ingénieurs qualité, la validation...

- Vous identifiez la documentation requise pour le projet avec l'équipe, en utilisant la méthodologie QRM et l'approche ASTM 2500.

- Vous assurez la mise à jour de la documentation et du calendrier du projet en collaboration avec les différentes parties prenantes.

- Vous aidez les services de maintenance et d'étalonnage à mener à bien leurs activités de projet.

- Vous assurez la mise en œuvre des procédures et des normes internes de la division et de l'entreprise.

- Vous soutenez la conception de base et de détail, le FAT, l'installation, la mise en service/SAT et la qualification (PQ) de l'EWP assigné.

- Vous soutenez le responsable EWP dans la rédaction des URS, FDS, protocoles pour la nouvelle extension de l'installation composée d'équipements de remplissage aseptique, de lyophilisateurs, de technologie d'isolateur (y compris la décontamination VHP), de systèmes CIP, de filtration stérile, de préparation de formulation et de tampon, de laveurs de pièces, d'autoclave, de processeur de bouchons et de préparation du matériel.

- Vous assurez la compatibilité et la cohérence avec les procédures existantes de l'organisation (site, division et entreprise) et les normes industrielles (cGMP, GEP, SUVA/ASIT, etc.).

- Vous définissez les mesures de sécurité appropriées et les mettez en œuvre pour prévenir tous les risques de blessures pendant le projet.

- Vous mettez à jour la pré-HAZOP et la HAZOP.

- Vous définissez des mesures de sécurité appropriées pour prévenir tous les risques de blessures pendant le projet.

Votre profil :

- Vous avez une première expérience en gestion de projets et notamment en extension d'usine.

- Français, anglais.

- Connaissance et utilisation des outils informatiques courants.

Votre contact Kelly :

Kévin Chauvin

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