Ingénieur(e) Procédés Upstream H/F

Description de l'offre

Sanofi Vitry-sur-Seine est l'un des sites les plus innovants du Groupe, avec plus de 2000 collaborateurs.

Doté d'un outil de production ultramoderne, le Biolaunch, le site maitrise à la fois les activités de recherche, de développement et de fabrication de biotechnologies.

Notre expertise ? Des produits visant à lutter contre le cancer et les maladies cardiovasculaires.

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

Within our local Manufacturing Science & Technologies (MSAT) organisation, we are looking for an experienced Upstream Process Engineer to join our expanding team based at Vitry in the Biolaunch Plant close to Paris (94). 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. In the daily Business, process engineer has in charge Change Controls, CAPAs and has to participate to investigations in case of deviations. The USP process Engineer has a SME role and has to contribute in case of inspection. The USP process Engineer will also have to develop the network within other Sanofi manufacturing sites and also with external partners.

Expertises in industrial biotechnology and cell culture

KEY ACCOUNTABILITIES

·  Ensure the analysis of manufacturing data and do the daily monitoring of process
·  Contribute to technical investigations of complex deviations in manufacturing and suggest efficient CAPAs
·  Thanks to his strong technical and scientific skills, ensure the process robustness and propose performance improvements in order to reduce cost of goods and increase productivity within quality and EH&S rules
·  Partners for introduction of new products in the facilility or modification on existing processes
·  Work transversally with other MSAT entities and internal or external partners (international)
·  Lead qualification /validation exercises
·  Ensure a close collaboration with manufacturing teams in shop floor to support batches (training, introduction of new technologies or processes…)
·  Participate to the redaction of operational documentations (ie SOPs, Porcess description, URS , CDO…. )
·  Lead Process validation (PPQ: strategy , protocol , execution , report )
·  As a SME in USP, will participate to Inspection (ANSM, FDA, GQA…)
·  Ensure the good respect of HSE and GMP rules (Aseptic conditions, Risk analysis….)

REQUIREMENTS

Education / Experience

·  Biotechnology Master degree or PHD with a specific experience (5-10) years in manufacturing (Mabs preferred)
·  USP technical and scientific skills (A pilot experience can be appreciated)
·  Experience in Process Validation
·  Experience in TT activities (GARAMP, FMEA…)

Technical skills & Competencies / Language

·  Mammalian Cell culture
·  GMP environments
·  BPD/BPF
·  SCADA system
·  French Fluent, English Fluent

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.