Freelancer profile translated to English.

Description

Expert in digital transformation in regulated industries (GxP, 21 CFR Part 11), I work on MES, CMMS, MDM, or ITSM projects, from scoping to implementation. I support my clients (Sanofi, CEVA, Nemera…) in modernizing their industrial operations, with a dual strategic and operational perspective.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
German
Basic

Workplace preferences

Can work on-site

Lyon (up to 50km), Paris (up to 50km), Aix-en-Provence (up to 50km)

ceva
Manufacturing & Quality Solution Owner
PHARMACEUTICALS INDUSTRY
January 2025 - Today (1 year and 5 months)
Libourne, France
IT Solution Owner for
- CMMS (GxP critical)
- OEE (non GxP) implementation
- IPC (GxP) initiation and roll out

Project Manager for
- Digital Microbio Plate implementation on a pilot site (Petri Box digitalization - GxP Critical)

Product management GxP Gestion de projet Project Portfolio Management
Nemera
PMO / Digital Transformation
PHARMACEUTICALS INDUSTRY
January 2024 - January 2025 (1 year)
Lyon, France
Implementation of a CMMS and an MES.
GxP data management
Data migration
Governance and VSI
Management of the integrator
21 CFR Part 11 Gestion de projet Implémentation
Viant
PMO / Senior Project Leader
PHARMACEUTICALS INDUSTRY
December 2021 - December 2023 (2 years and 1 month)
Chaumont, France
Responsible for new industrialization projects.
Management of 7 project managers
Revalidation project of an hydroxyapatite coating on a shoulder implant as part of a dossier resubmission (MDR compliance).
Validation project of a Titanium coating on a cervical implant.
Industrialization project of an ankle implant.
Industrialization project of an arthroscopy kit (micro-machining)
Validation project of a tensile testing method.
Validation project of a Willemin machining machine.
ISO 13485 / 21 CFR
Work exclusively in English
Gestion de projet Dispositifs médicaux projection plasma Usinage Cross-functional Team Leadership