denis osbert
Senior Consultant | GMP & Sustainability
Salaire / Taux journalier
38330 Montbonnot-Saint-Martin, France
Mobilité : Paris, Bruxelles, ...
Freelance, ouvert au CDI
Peut venir sur site
Expertises
Langues
À propos
Introduction
GMP/FDA consultant with 30+ years expertise in pharmaceutical facilities and medical device projects. Led 50M$ greenfield construction in Hungary, coordinated worldwide sustainability programs saving 5-10M$ annually across 80+ plants, and performed 40+ compliance assessments globally. Specialized in clean room design, critical utilities, and combining GMP requirements with sustainability for regulated industries.
Expérience de travail
Consultant
Denis Osbert ProjectFreelance
avr. 2021 - Présent
5 ans 7 mois
worlwide
Consulting Build 2030 roadmap for sustainability project - BD Business unit-26 plant worlwide Support - Procedure work for Commissioning and Qualification clean room - Construction Group Consulting for GMP design new plant - Medical device industry
Consultant
DENIS OSBERT PROJECTFreelance
août 2020 - Présent
6 ans 3 mois
69340 Francheville, France
BD
avr. 1992 - mai 2020
28 ans 2 mois
Worldwide Sustainability / GMP design manager
janv. 2015 - mai 2020
5 ans 5 mois
Sustainability and energy wordlwide manager in medical devices industry Sustainability targets/goals , audits . HVAC, CA , clean room , pharmaceutical critical utilities ,energy consumption reduction. building tools , training , support plants , indicators , waste management Performing more than 40 sustainability assesment WW 300 to 500 projects / savings 5 to 10 M$ a year Scope more than 80 plants around the world , Expert in GMP/ FDA regulated facilities , including critical utilities QA risk assesment . GMP assesment ( ISO ,YY, NOM GMP ) assesment/ audits/ documentations review , protocols , design , flows, clean rooms design, risk analysis Combine GMP et Sustainability , with the technical expertise on what can impact the environmental quality of the product = contamination reduction
Worldwide Project coordinator - Phamaceutical segment
sept. 2009 - janv. 2015
5 ans 5 mois
Grenoble et périphérie
WW coordinator and projects support for the segment activities: feasibility, budget, planning, investment, OPEX, CAPEX and reporting for construction and FM =1 to 20 M US$ / year. Design studies for a new plant in China .Construction and process /Capex / Design implementation/Design review/ Engineering Microbiology laboratory in Mexico Utilities obsolescence and production area in France Segment activities locations =UK/France/Hungary/Japan/Mexico/US/ China. GMP/FDA design expert for critical utilities WFI ,EDI , HVAC cascade pressure , room classification WW sustainability coordinator for segment Support to restart the Fukushima plant after 2011 earthquake / visit to estimate re-start feasability 3 weeks after earthquake
New plantconstruction coordinator Hungary
avr. 2006 - oct. 2009
3 ans 7 mois
Construction project coordinator of a new industrial facility site in Hungary . Land surface 21 hectares, building 31 000 m², budget 50 M$. Pharmaceutical finishing according cGMP. Full management of the project (Greenfield) land selection, pre-design , design , construction commissioning, validation, equipment installation, permitting, Interface with multiculturral team ( engiennering equipemnt, quaility , IT , HR, Facilities, training, HR, Finance ,
Facilities manager
avr. 1992 - mai 2006
14 ans 2 mois
Grenoble, France
Facilities manager for the Grenoble plant + WW segment headquarter 10 to 30 M$/year investment and contract site extended from 550 to 1800 people
Formation
ESTP
Master, Facilities management
2005 - 2005
1 an
AFPA
Licence, Ecole des conducteur de travaux BTP - AFPA Toulouse
1990 - 1991
2 ans