Manufacturing Engineer
Vor 2 Tagen
À propos du poste:
Spécialisé dans la gestion des Systèmes Informatisés et Systèmes Automatisés de production
Au sein du département « IT Manufacturing» du site de production de Neuchâtel (approx. 700 collaborateurs), dans le secteur de l’hématologie, nous recherchons un ou une «Manufacturing Engineer». Il s’agit d’une belle opportunité pour quelqu’un de dynamique, autonome, force de proposition et ayant une agilité professionnelle pour intégrer une équipe pluridisciplinaire.
Dans cette fonction, le «Manufacturing Engineer» supportera et interviendra dans les différents processus gérés par le groupe «IT Manufacturing», y compris la gestion de la documentation et des Systèmes Informatisés et Systèmes Automatisés de production.
Le «Manufacturing Engineer» rapportera au «Manager IT Manufacturing».
Responsabilités:- Être «Business Process Owner» pour les différents Systèmes Informatisés et Systèmes Automatisés (SISA) utilisés dans les trois unités de production.
- S’assurer que les exigences en lien avec les SISA sont respectées, à savoir :
- La réalisation des revues de performances périodiques de ces systèmes.
- L’évaluation des impacts et/ou la conduite des Change Control/Déviations sur ces systèmes.
- Le maintien en conformité des systèmes par rapport aux exigences réglementaires (par exemple, les exigences en termes d’intégrité des données).
- Diriger, effectuer et examiner les évaluations des risques/écarts liées aux équipements de fabrication et aux données associées.
- Participation à la gestion de projets concernant les unités de production.
- Participation à la gestion de la documentation de production des trois unités de production.
- Soutenir le projet Data Integrity pour l’ensemble de l’usine de fabrication.
- Bachelor, Master, CFC ou BAC + 2 avec une expérience confirmée (3 à 5 ans) dans le domaine de l’industrie pharmaceutique ou un autre secteur d’activité appliquant les cGMP.
- Bonne connaissance en Systèmes Informatisés et Automatisés (SISA) appliqués dans le secteur de la production.
- Bonne connaissance des règlementations «Data Integrity» et leur application sur des systèmes de production.
- Très bonnes connaissances des règles de Bonnes Pratiques de Fabrication (BPF).
- Méthode, organisation, autonomie et rigueur dans le travail.
- Capacité à penser et à agir de manière interfonctionnelle, à interagir avec des experts, des SME, des ingénieurs, etc.
- Une formation ou une expérience en gestion de projet est un atout (de l'URS à la mise en œuvre).
- Expertise en qualité / conformité dans un domaine de fabrication réglementé par la FDA / GMP requise.
- Approche structurée et orientée-solution, capacité à simplifier ce qui est complexe.
- Disponibilité et flexibilité avec un fort esprit d’équipe.
- Caractère dynamique et volontaire.
- Très bonne communication verbale et écrite en français et en anglais, B2 minimum.
Salaires compétitifs, couverture complète des accidents, participation aux primes d'assurance maladie, plans de retraite avantageux, repas subventionnés, participation financière aux activités sportives de ses employés, soutien aux abonnements du transport public local, parking gratuit, programme de covoiturage.
Takeda Neuchâtel offre à ses collaborateurs un cadre et des conditions de travail attractifs. Le bien-être et la sécurité, le développement et l'évolution de carrière de ses collaborateurs sont au cœur de nos politiques Ressources Humaines, Santé, Environnement et Sécurité.
Takeda Neuchâtel est un employeur engagé envers ses collaborateurs et les générations.
En savoir plus sur Takeda Neuchâtel:Avec plus de 700 collaborateurs, Takeda Neuchâtel est l’un des dix plus grands employeurs du Canton de Neuchâtel et l’un des sites de production biopharmaceutique de référence en Suisse. Actif 24 heures sur 24 et 7 jours sur 7, le site emploie un large éventail de professionnels formés aux biotechnologies et à leur application dans la production industrielle. Avec plus de vingt nationalités, Takeda Neuchâtel offre un environnement de travail international, diversifié et innovant au sein d’une entreprise ancrée et engagée dans son écosystème local. Takeda Neuchâtel est certifiée Entreprise Formatrice par le Secrétariat d'Etat à l'Economie Suisse. Nous formons des jeunes apprentis dans divers domaines tels que le contrôle qualité en laboratoire, la logistique, l’informatique et la production biopharmaceutique.
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