Maurepas
PROJECT MANAGEMENT
8 year’s experience in Project Management: Installation of production equipment in pharmaceutical GMP production site, from the conceptual design to the qualification and handover to the users
Management of a project team, up to 10 people
Principal contact for suppliers and internal clients during the project
Project planning and budget forecast & management
Coordination of project activities during shut down periods of the production plant
QUALITY
Regulatory compliance knowledge: cGMP, BPF, GAMP, ISO 9001/14001/50001
Writing, review and approval of quality documents (Master Validation Plans, procedures, protocols and reports)
CAPA knowledge and leadership
Participation to internal and external audits (regulatory, FDA)
Qualification of mechanical and automated systems or equipment
TECHNICAL SKILLS
Process equipment knowledge: Bioreactors, purification & chromatography skids, filters skids, buffer preparation, freeze-dryers
Biotechnologies processes general knowledge (education)
Utilities equipment including water pretreatment, WFI generation and distribution, chemicals docking station and distribution, pure steam generation & distribution, CIP station, HVAC, sterilizer & washing machine, wastewater degradation & neutralization treatment
Facility equipment (boiler, chiller, electricity & back-up generator), clean rooms, building offices
Energy Management: Consumptions & CO2 emissions follow-up , Corporate reporting
Management of Facility Energy Business Plan (Excellence Baxter Corporate obtained in 2009)
Execution & participation to Energy audit assessments
Energy Projects Management: Heat pump recovery, renewable energies (solar panels), Building management system, lighting
MEMBERSHIP
ASHRAE, ISPE: Review of draft guidelines
ISPE trainings: HVAC for Pharmaceuticals Facilities, Pharmaceutical Water Systems
LANGUAGES
French (Mother language), English (advanced knowledge),
German & Spanish (basic knowledge)
SOFTWARE
MS Project & Office, Access, Autocad, Johnson Controls Metasys, Siemens Desigo
Mes compétences :
Gestion de projet
Qualité
Biotechnologies
Ingénierie
