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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

Verification & Validation Designer (F/H)

Location : Saint Priest, Lyon

 

 

WHO ARE WE ?

 

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.

 

We are looking for our new Verification & Validation Designer.

 

 

 

The principal responsibilities of the role are :

 

 

Owns Design Verification and Validation activities during development of new consumable medical devices:

 

 

  • Defines and owns V&V plans (including sampling strategy) & reports
  • Questions and challenges Design Inputs to guarantee the ability to be verified and validated (specifications shall be complete, unambiguous, verifiable or apt for validation and non-contradictory)
  • Turns product specifications into testing protocols
  • Defines adapted testing lots & validated methods to evaluate product & packaging performances during simulated life cycle (sterilization, transport, ageing etc)
  • Defines necessary pre-verification activities
  • Schedule, lead and follow up of internal / outsourced testing activities
  • Identifies, specifies and requests needs in human resource
  • Follows their obtention and manage contractors when needed
  • Ensures and maintains adequate team members skills regarding the activity requirements
  • Collaborates with Consumables Sustainment Coordinator regarding shared resources
  • Ensures technical reporting and participates to budgetary tracking (quality, costs, timeline)
  • Contributes to Usability Evaluation File & Design Validation

 

 

Owns new consumables testing equipment at the lab:

 

  • Identifies and specifies needs in technical equipment for the testing lab with regards to automation / parallelization. Requests & follows their obtention
  • Development, installation & qualification of measuring/testing equipment of in-house testing facility + externalization of tests
  • Contributes to CSV activities on testing equipment

 

Participates to sustainment of the group consumable medical devices portfolio:

 

  • Keeps DHF of products legally manufactured by Guerbet and its affiliates up to date and according to applicable regulations
  • Provides support to change controls on legacy products
  • Provides support to distribution of products by Guerbet and its affiliates

 

Others:

 

  • Impact analysis on new/updated regulations identified by Regulatory Affairs
  • Technological watch

 

 

YOUR PROFILE
 
More than your degree, your personality and your skills will make the difference: able to communicate effectively and professionally with peers, company personnel and customers to resolve service issues and promote company services. You have strong technical and excellent communications skills.


 
Competencies and Experience


 

  • Engineering/life sciences or equivalent validation experience
  • 10 years of validation experience in a pharmaceutical environment or equivalent
  • Good command in managing customer accounts relative to service matters
  • Fluent in French and English 
  • Self-motivated, energetic, enthusiastic, and team oriented.
  • Effective communication with both team members and other plant support groups