Chargement...
Partager cette offre d’emploi

Guerbet est un leader mondial de l'imagerie médicale, proposant une large gamme de produits pharmaceutiques, de dispositifs médicaux, de solutions numériques et d'IA pour l'imagerie diagnostique et interventionnelle, afin d'améliorer le diagnostic et le traitement des patients.

Pionnier depuis plus de 90 ans dans le domaine des produits de contraste, Guerbet innove en permanence avec 9% des revenus dédiés à la Recherche & Développement et quatre centres en France, en Israël et aux États-Unis.

Guerbet (GBT) est cotée sur Euronext Paris (segment B - mid caps) et a réalisé un chiffre d'affaires de 817 millions d'euros en 2019 avec plus de 2 800 collaborateurs dans le monde.

Achieve, Coorperate , Care et Innovate  sont les valeurs que les employés de Guerbet partagent et pratiquent chaque jour. Travailler chez Guerbet, c'est jouer un rôle unique dans l'avenir de l'imagerie médicale. Passionnée par son métier, l'entreprise s'efforce jour après jour de conjuguer performance, qualité et développement durable.

Pour plus d'informations sur Guerbet, rendez-vous sur www.guerbet.com  et suivez Guerbet sur Twitter @GuerbetGroup

Plastic Senior Development Engineer M/F

Location: Villepinte (93), France

 

The Senior Development Engineer is responsible for the entire set of plastic components that serve as the primary package(s) for Guerbet products.

These components are developed under various criteria (ex. functional performance, regulatory requirements, USP, and other industry standards), PFS and vial components are developed to meet/exceed performance and injection method criteria set by the organization and industry.

 

Essential Functions

 

  • Support current PFS component life-cycle management activities including any Guerbet or vendor proposed changes.
  • Support new PFS component development.
  • Support new plastic container launch for future Guerbet products
  • Lead component qualification (mold validation) efforts.
  • Document component qualifications (mold validations) – IQ/OQ/PQ. 
  • Investigate conditions in which component(s) are found to be non-conforming.
  • Develop strategies to address complex component production challenges.
  • Advance relationships with internal and external stakeholders in order to best support PFS component development, production, and delivery. 
  • Apply Six Sigma and statistical tools/methods/techniques throughout component and mold lifecycle  
  • Anticipate, characterize, identify, and eliminate defects or reduce unfavorable process influences. 
  • Communicate complex or technical challenges to internal & external stakeholders in order to protect the business and advance PFS product development. 
  • Support production related activities at Guerbet facilities and CMOs (contract manufacturing organizations). 
  • Participate in vendor qualification efforts focused on improvements in quality, cost, and delivery. 
  • Identify and oversee external labs to execute qualification testing per various ISO requirements. 
  • Disseminate long-term capital budget for PFS molds supporting future production introductions. 
  • Conduct cost estimating, budgeting, and analysis
  • Perform other duties and special assignments as needed

 

Your profile

 

  • Holder of an Engineering degree  
  • Experience in product design and development under industry guidelines (USP)
  • Knowledge in component qualification and mold validation into pharmaceutical industry
  • Proficiency in Solidworks or similar 3D modeling program
  • Exposure to combination drug products
  • Knowledge of plastics and elastomers used in drug packaging
  • Familiarity with plastic injection molding and elastomer compression molding
  • Good command in applying Six Sigma techniques, methods, and tools
  • Familiarity with project management techniques and tools
  • Ability to lead cross-functional teams