Ingénieur Procédé USP (H/F)

Job description

« 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. »

The R&D and Production Platform of Vitry/Alfortville is an established site within the Sanofi network. Created in 1908 and located 3 km outside Paris, this Platform is structured around two activities: Research and Development, and the production of new chemical and biologics based treatments, particularly in the areas of cardiovascular diseases and cancer. The site has almost 2000 staff who together with their world renowned scientific and manufacturing expertise and excellent infrastructure to drive research, development and production, makes Sanofi a leader in the provision of innovative health solutions for patients all over the world.

Over the last decade, Sanofi has invested significantly in the research, development and manufacturing of biologics both globally and locally at the Vitry-sur-Seine site, including our biologics manufacturing facility, which is one of the largest industrial-scale cell culture facilities in France.

At the Vitry-sur-Seine site we have a large team of scientists and engineers specialized in biological process development and engineering, who work closely with the industrial teams in order to integrate all of the expertise, skills and technology needed for the development and industrialisation of new innovative biologics products, for example monoclonal antibodies.     

Within our local Manufacturing Science & Technologies (MSAT) organisation, we are looking for an experienced Upstream Process Engineer to join our expanding team. The MSAT team provides technical and scientific support to our Manufacturing teams together with driving continuous improvement and operational excellence. The MSAT group is also responsible for Technology Transfer and Process Validation activities on site. 

KEY RESPONSIBILITIES

·  Owns the technology transfer of a new or modified manufacturing process being transferred from our R&D or industrial network partners to Vitry-sur-Seine
·  Supports the site in investigations including process deviations and identifying effective CAPAs
·  Key stakeholder in process validation activities
·  Avid ambassador of cGMP guidelines and HSE policies
·  Drives continuous process robustness and improvement in order to make processes more cost effective at the same time maintaining quality and HSE requirements
·  Supports manufacturing team in day-to-day process management
·  As an upstream processing SME, will be required to support inspections & audits (ANSM, FDA, EMEA etc.)

REQUIREMENTS

·  Biotechnology master / engineer degree or PHD
·  Experience  min. 5 years in Biotechnology
·  Experience  and process validation, preferably biologics processes
·  Experience in cell culture  (large scale bio reactors and cell culture clarification)
·  Experienced in cGMP (clinical or commercial biologics manufacturing)
·  Good knowledge of regulatory requirements for biologics manufacturing
·  Fluency in French and English

Sanofi obtient la certification globale et France de 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.