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PHARMACHEM, Grand Bahama, FREEPORT
- Project Leader Automation IT new plant
2018 - maintenant
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PHARMACHEM
- Owner SARL
2018 - maintenant
* Siemens, DELTA-V, Desigo Siemens, Panorama software, ACRONIS
* Microsoft Office
A voir mon CV attache
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Glaxo Smith Kline
- Project leader in maintenance department
2017 - 2018
as a gate keeper between the routine departments and the Engineering service in ``New Product Industrialization'' Building. The direction wished me to develop the engineering entity for this building but the account was refused.
* The building ``New product Industrialization'' has been handover from the Engineering to the final users. My mission as freelancer is to evaluate the new requests by the users, with feasibility and cost control, concerning the packages Environment monitoring, Alarm monitoring, Gas detection, Facilities... (HVAC, BMS via Panorama software), Lyophilisator and filling machines.
Page 1 of 4 Excellence from Concept to Completion
* Then, the main target of the mission is to apply DATA INTEGRITY into this building in case of audit. My position is to help the GIO team in process control for all the machines(RACI2) in this building.
* Support to GIO Team for process control in terms of DATA INTEGRITY.
* Coordination on the field due to EHS aspects or new requests (access control, fire detection, HVAC, facilities, electricity, data, furniture)
* Prepare and Coordination activities during the shutdown periods (3 weeks in August & 2 weeks in
December); Maintenance, QA, Users, Calibration, Cleaning activities.
* Follow-up punch list between engineering team and R&D users about LYOPHILISATOR machine, HVAC packages, and WFI utilities.
* Meeting room / maintenance office in place.
* Re-start production activities on time after shutdown.
* Machine LYO, installation new server and qualification to assure the redundancy (Process Control, Data Integrity).
* Review with the users of all the reports Data Management Control, for all the machines.
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Glaxo Smith Kline
- Project Manager, Belgium Maintenance department & freelancer
2016 - 2017
Vaccines - Wavre / Rixensart / Gembloux in Belgium Project Manager, Belgium Maintenance department, (freelancer)
* My mission was to set up and deploy a new version of the alarm monitoring software through the entire sites in Belgium (Wavre, Rixensart and Gembloux) with a partnership contractor using the software on smartphones instead of ``BIP'' devices.
* This project was a pilot project in GSK to deploy after that in GSK France, Singapore, and Hamilton... This project cost 500k EUR in order to reply to FDA remark.
* User request system written
* Sourcing contractors
* I did the Cost-breakdown defining also the milestones and penalties (total cost 500k EUR )
* I have developed the strategy of communication and training sessions (1800 users)
* I have managed the Training team to be compliance with the SOP during the software updating period.
* I have assured the coordination during the Commissioning and qualification phases with Compliance, QA, IT departments.
* I have managed technical team to deploy the new software after the C&Q phase.
* I was responsible to buy and distribution of 500 smartphones devices (Human resources / procurement / Telecommunication departments discussion)
* AMS software has been deployed on Belgium sites and was ready to be extended to the other sites.
* People trained and using the new software.
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Glaxo Smith Kline Vaccines
- Project leader
2015 - 2015
* Project Leader in FDA remediations (Archestra migration, decontamination stations, leak detection) in Automation Maintenance department. (as freelancer).
* My mission was here to give some projects to the maintenance team to justify and assure a job for the next
3 years, (25 technicians).
* I have written the URS, and then make the sourcing contractors, next the cost breakdown, to conclude in making the Kick off meeting.
* Archestra Migration for all the machines due to IT central solution.
* Software PEMS (Particle Environment Monitoring System) Migration in QC Building
* 3 Decontamination Stations in Rixensart site
* Apply leak detection system on all the sites
* Remarks FDA closed or actions taken
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Glaxo Smith Kline Vaccines
- Project Manager
2015 - maintenant
maintenance department, gestion contractors, costbreakdown, cost control, software projects..
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Glaxo Smith Kline Vaccines
- Projet Leader
2010 - 2015
* It was a Greenfield project to build a new industrialization building with 4 production units where I could integrate the Europe Engineering Process Control GSK Team as a project leader.
* The total cost of this building was 500M EUR .
* Foster Wheeler Italia was the engineering office; I was in charge to follow the special systems from the basic design phase to the Handover.
* BMS; Building Management System
* DATA: Architecture (7 telecom rooms)
* Fire detection (4 cabinets)
* Gas detection (4 cabinets)
* AMS: alarm monitoring systems (7 cabinets)
* PEMS: particle environment monitoring system (12 cabinets)
* Access control / Interlocking Doors (HID, NEDAP, C-cure): (12 cabinets)
* CCTV: control camera
* ATEX / Cold Room: 2 clean rooms
* Monitoring vessels on DELTA-V
* Basic and Design studies.
* Sourcing contractors and define limit battery.
* Construction supervision; follow-up and management of the contractors
* Manage and co-ordinate the Commissioning Trade Contractor
* Assist and expedite commissioning documentation prep / review /approval
* Track commissioning progress, report same to the Team Lead
* Ensure that punch-list items from Construction and commissioning phase are tracked to completion
* Liaise with Client SME's and User Reps
* Execute Verification documents for qualified cold rooms, qualified clean rooms
* Assist & coordinate the C&Q activities
* Handover and training to the final users
* I was the main technical support during the FDA and Belgium Legal (FMPS) inspections
* Closing punch list for the building (black piping / clean piping / finishing...)
* The handover of the entire building has been done.
* The FMPS and FDA Audits were a success in this new building.
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GSK vaccines
- Project leader Freelance
2010 - 2015
Basic Design / Detail Design sur des systèmes automatisés with Foster Wheeler.
Environnement/ Alarm Monitoring System / Process Control System / Delta V
Emergency Shut Down.
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Glaxo Smith Kline Vaccines
- Ingenieur Projet
2008 - 2010
Glaxo Smith Kline Vaccines - Saint-Amand-les eaux, FRANCE
* It was a Greenfield project for a new production site (6 new buildings). I have integrated the Automation
Engineering GSK team as project Engineer during the phases of construction. The Engineering offices were
NNE Pharma Denmark and SNC Lavalin.
* I have worked on two buildings of production, one of utilities and the last one as Laboratory.
* My mission was to follow up and assure the construction phases and make the commissioning and qualification of the following packages: Facilities, Secondary equipment's, Gas detection system, Alarm
Monitoring System, Environment Monitoring System, Pure water loop (Siemens) Washing machine.
Autoclave, Docking station vessels (Siemens S7)
* Buildings are now in production
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Glaxo Smith Kline (Saint Amand les Eaux)
- Project Engineer
2008 - 2010
Project Engineer
Department : Process control / automation.
few projects :Gas detection / Docking Station / Floor scales / CIP Station/ Washing machine / autoclave
Action :
FAT
Coordination construction / team work
Commisionning/SAT
IQOQ
Handover
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MACOPHARMA
- Ingenieur methodes
2006 - 2008
* The production plant wanted to increase the productivity in deploying a Lean project manufacturing of perfusion and blood transfusion kits.
* My mission was to improve the methods of production to participate to this project.
* Installation, qualification and start-up of new filling machines.
* Training of people in France and Poland.
* Optimization of material flow inter-site: Methods, training and logistic inter-site with Tunis.
* Lean Manufacturing project is now in place, and people trained. Unfortunately, the ROI was not what was expended.
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MACOPHARMA
- Ingenieur Methodes
2006 - 2008
Contexte et objectifs :
Entreprise pharmaceutique spécialisée dans la fabrication des kits de transfusion sanguine.
------------------------FRANCE--------------------------------------
- Mise en place d’un projet Lean Manufacturing augmentant la qualité des produits, la productivité tout en baissant les coûts de revient.(40000kits/jour)
- Achat et mise en place de nouveaux équipements de remplissage de solution en salle « blanche »
Activités realisees:
Achat de nouvelles machines :
- Rédaction du cahier des charges fonctionnel
- Sourcing Fournisseurs
- Mise en avant des avantages et des inconvénients des différentes solutions au directeur du site.
- Achat Machine
- Suivi montage et mise au point et réceptions
- Installation : Gestion des travaux avec des équipes pluridisciplinaires
- Management tranversal avec des personnes de formation différentes
- Qualification du processus
- Formation du personnel
- Suivi de production
- Étude de capabilité,
- Relations inter services et internationales.
Résultats :
- Nouvelles machines installées. Nouvelle technologie plus stable et donc une diminution de la fréquence des contrôles, une augmentation de cadence (gain de 7% de TRS). Gain de 500k€/an.
----------------------------------TUNISIE---------------------------------
Contexte et objectifs :
Entreprise pharmaceutique de sous-assemblage des kits de transfusion sanguine (fournisseur du site français)
- Augmenter les cadences de productivité.
- Améliorer le conditionnement des produits
Activité(s) :
- Adapter leur production à nos besoins en France.
- Optimiser leur production et l’aménagement de postes de travail
- Organisation de l’approvisionnement de matière entre les différents sites.
- Application des étapes de montages dans les deux sites.
Résultats :
- Gain apporté au groupe de 40k€/ an
------------------------------POLOGNE/FRANCE-------------------------------
Contexte et objectifs :
Industrialisation d’un système d’injection de solution dans un nouveau produit.
- Augmenter les cadences de productivité.
- Améliorer le conditionnement des produits
Activité(s) :
France :
- Rédaction du cahier des charges fonctionnel
- Travail en équipe avec le service R&D
- Sourcing Fournisseurs
- Mise en avant des avantages et des inconvénients des différentes solutions au directeur du site
- Achat Machine
- Validation
- Mise en place sur les convoyeurs sur le site français
- Formation du personnel
Pologne :
- Travail en équipe avec le service méthodes de Pologne
- Transfert de compétences
- Mise en place des machines
- Formation du personnel
Résultats :
- Le nouveau produit industrialisé sur les deux sites de production.
Environnement et savoir faire technique :
- Salle blanche sous atmosphère contrôlée, normes FDA
- Gestion de projet,
- Etude de capabilité
