Safety System Principal Engineer H/F

Job description

Le site du Trait en Normandie produit des seringues pré-remplies de médicament à destination d’un large public. Notre ambition est de renforcer notre position d’usine injectable faisant partie des plus performantes d’Europe de l’Ouest.

Le site a concrétisé sa démarche de diversification en relevant le défi du lancement d’un nouveau produit injectable issu de la biotechnologie

Notre produit phare ? Un anticoagulant fréquemment utilisé dans le cadre d’interventions chirurgicales.

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail. 

SCOPE

The scope will include elements of the core technical capability, coordination and operational execution of component development programs and support to industrialization programs needed to implement anti-needle stick safety systems for Prefillable Syringes in Drug Device Combination products.

PRINCIPAL ACCOUNTABILITIES

Defines, in liaison with the PCD Head, the technical roadmap for Safety Systems. Support transfer of developed safety system platform components, through the PCD Late Stage PFS development teams, to R&D DP Centers and IA manufacturing centers, for implementation in Late Stage DDC. Responsible for Safety system component development activities, with relevant external partners (design house, third party component suppliers, molding and assembly providers). Defines component and system specifications, including associated method developments, for platform safety system components. In liaison with the PCD Lab network and expertise coordinator, defines and supports method deployment.  Support MSAT organization in the transfer and industrialization of Safety Systems on relevant industrial sites. Review (directly or by delegation) documentation related to safety system process development (including Process FMEA) and validation.  Act as a global SME in Primary Container development and troubleshooting, supporting industrial sites, IA/CMC, global quality and investigation teams with PCD Safety system development team technical capability and expertise.

REPORTING STRUCTURE 

The Safety System principal engineer has a solid reporting line into the Head of PCD group.

REQUIREMENTS / COMPETENCIES

·  Engineering degree or equivalent in mechanics, material science, medical device.
·  >7 years in the development and manufacturing of pharmaceutical products, targeting injectable delivery.  
·  Strong technical background in medical device technologies, including a solid expertise in the design, development and manufacturing processes.
·  Prior experience in Anti-Needle Stick devices development, industrialization and qualification within pharmaceutical operations would be a plus.

Competencies :

·  Systems engineering understanding and application experience in a regulated environment. Additional required technical competencies or understanding include plastic molding, plastic assembly, high volume pharmaceutical assembly and inspection, device development and design, risk assessment and FMEA.
·  Operational competencies for high-volume production and design transition into high-volume production environments.
·  Ability to operate in an international, cross-company and cross-functional environment. - Professionalism and demonstrates solidarity with organization and team members. - Communication and inter-personal skills necessary to build trust, confidence and collaboration toward shared objectives. - Creativity and common sense. - Issue and conflict analysis and resolution across all levels of an organization, as well as external partners.
·  Project management competencies in areas such as resource planning and management, project planning and management, and risk planning and management are required.
·  Language - Good communication skills (written and oral) - Written and oral fluency in French and English is required. -

SCOPE

The scope will include elements of the core technical capability, coordination and operational execution of component development programs and support to industrialization programs needed to implement anti-needle stick safety systems for Prefillable Syringes in Drug Device Combination products.

PRINCIPAL ACCOUNTABILITIES :

·  Defines, in liaison with the PCD Head, the technical roadmap for Safety Systems. Support transfer of developed safety system platform components, through the PCD Late Stage PFS development teams, to R&D DP Centers and IA manufacturing centers, for implementation in Late Stage DDC.
·  Responsible for Safety system component development activities, with relevant external partners (design house, third party component suppliers, molding and assembly providers).
·  Defines component and system specifications, including associated method developments, for platform safety system components. In liaison with the PCD Lab network and expertise coordinator, defines and supports method deployment.
·   Support MSAT organization in the transfer and industrialization of Safety Systems on relevant industrial sites. Review (directly or by delegation) documentation related to safety system process development (including Process FMEA) and validation. 
·  Act as a global SME in Primary Container development and troubleshooting, supporting industrial sites, IA/CMC, global quality and investigation teams with PCD Safety system development team technical capability and expertise

REPORTING STRUCTURE 

· 
The Safety System principal engineer has a solid reporting line into the Head of PCD group.

​ REQUIREMENTS / COMPETENCIES

·  Engineering degree or equivalent in mechanics, material science, medical device.
·  >7 years in the development and manufacturing of pharmaceutical products, targeting injectable delivery.  
·  Strong technical background in medical device technologies, including a solid expertise in the design, development and manufacturing processes.
·  Prior experience in Anti-Needle Stick devices development, industrialization and qualification within pharmaceutical operations would be a plus.

Competencies:

·  Systems engineering understanding and application experience in a regulated environment. Additional required technical competencies or understanding include plastic molding, plastic assembly, high volume pharmaceutical assembly and inspection, device development and design, risk assessment and FMEA.
·  Operational competencies for high-volume production and design transition into high-volume production environments.
·  Ability to operate in an international, cross-company and cross-functional environment. - Professionalism and demonstrates solidarity with organization and team members. - Communication and inter-personal skills necessary to build trust, confidence and collaboration toward shared objectives. - Creativity and common sense. - Issue and conflict analysis and resolution across all levels of an organization, as well as external partners.
·  Project management competencies in areas such as resource planning and management, project planning and management, and risk planning and management are required.
·  Language - Good communication skills (written and oral) - Written and oral fluency in French and English is required.

Sanofi has been awarded Global - France Top Employer 2019 !

Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d'inclusion et créer un environnement de travail où ces différences peuvent s'épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous. Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.