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Greenwatt
maintenant
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Greenwatt
- Project Manager
2009 - maintenant
Project Management
Engineering new projects
EPCM
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Greenwatt sa / Biogaz plants
- Consultant
2009 - maintenant
* Project management ;
* Validation
* Technical consulting
Management of engineering & projects team within a renewable energy company
Engineering / procurement / construction Management / commissioning / start up
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GSK
- Production Unit Manager
2008 - 2009
* Aseptic filling production lines management. ;
* Technical projects:
* Modification of an isolator filling line in order to improve the air flow pattern and complete requalification of VHP sterilization process (Vaporous Hydrogen Peroxide) - User. ;
* Automatic visual inspection: qualification of automatic cracks inspection in glass vials - Project leader.
Organizational project:
Complete filling process mapping in order to improve overall efficiency of the line (process mapping and Overall Equipment Efficiency evaluation). Definition and roll-up of KPI's (Key Performance Indicators).
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PFIZER
- Pilot Plant Operations Manager
Paris
2007 - 2008
* Planning, organization and execution of pilot plant operations to support multiple Veterinary Medicine full development biological vaccine projects. ;
* Performance qualification of pilot plant equipment in order to grant approval from Belgian health authorities (AFMPS) ;
* Equipment validated: filling line, autoclave, formulation tank, closed system connections and transfer line, freezer dryer and decontamination area system
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PFIZER
- Project Engineering Manager
Paris
2001 - 2007
* Ensure the completion of Capital Budget Plan according to User's needs, cGMP's rules, EH&S Guidelines, legal requirements and Corporate Guidelines. ;
* Lead the Engineering department of Pfizer LLN.
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PFIZER
- Development/Production Process Engineer & Development Process Engineer
Paris
1997 - 2001
Tasks as Development Process Engineer
* Study the production processes of new products (vaccines) based on existing product documentation such as Regulatory submissions and Development reports. ;
* Collaborate closely with Pfizer Global Research and Development (US based) in order to ensure Technology Transfer for new products (vaccines) and Process Robustness of process at Pfizer LLN.
Tasks as Production Process Engineer
* Translate manufacturing needs to Engineering and Maintenance Department in the acquisition, installation, start-up, upgrade of processes and equipment. ;
* Production processes improvements studies. ;
* Analysis and definition of User Requirement Specifications (URS) as well as the requirements for compliance with cGMP, licenses and safety criteria through close collaboration with Operations Managers and Teams in order to ensure that Company's standards are met. ;
* Equipment specifications; close collaboration for the writing up of the ``technical specifications'' with Engineering department. ;
* Review / write up of SOP's, protocols for equipment operation and validation (Clean-In-place, Steam-In-Place) ;
* Technical interlocutor on equipment issues with Engineering and Maintenance Departments ;
* Project leader on several implemented ( Aseptic filling line, CIP / SIP formulation tank, automated transfer line for parenteral vaccine, supply of gamma-sterilized HDPE vials) ;
* Collaborate to the establishment of the Validation Master Plan ( IQ/OQ/PQ).
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HUCKERTS INTERNATIONAL
- Production Manager
1996 - 1996
Responsible for the installation and operation of a new production clean room and production equipment.
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PHYSIOL s.a.
- Assistant to the Director
1995 - 1995
ISO 9001/EN 46001 Implementation (Medical Device EU Directive).
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DIVERSIFIED TECH.
- Production Manager
1992 - 1995
* Responsible for the industrial production of B.O.P. copolymer
(Biocompatible Osteoconductive Polymer), internal implant made of composite material and used in neurosurgery and orthopaedics.
* Development and validation of polymer synthesis process ;
* Process Flow Chart and secondary production line validation, according to EU cGMP. ;
* Development of Quality Control methods and SOP's. ;
* Research and development of new production technologies for B.O.P.
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UNIVERISTY OF LIEGE
- Development Process Engineer
1990 - 1992
* Research project financed by the Région Wallonne for DTI s.a. in collaboration with the Université de Liège. ;
* Research and development of organic synthesis of BOP, copolymer for medical usage. ;
* Process scale-up at pilot and industrial levels. ;
* Responsible for industrial production (synthesis and purification), in collaboration with sub-contractors: SIPSY, France; OMNICHEM, Belgium.
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UNIVERISTY OF LIEGE
- Process Engineer
1987 - 1990
* Research and Development, pilot scale-up of a bio-leaching process. ;
* Implementation of pilot bio-leaching process on site (Morocco, Company O.N.A.)
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UNIVERISTY OF LIEGE
- Researcher
1986 - 1986
* Purification of proteins. Purification of D-Amino-Acid-Oxidase ( DAAO ) ;
* Production of - lactamase by immobilised cells technology (Pilot plant)
