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Sanofi Pasteur
- Qualification responsible, SQO - Consultant for Consultys
Lyon
2019 - maintenant
Within Site Quality Operations (SQO) Qualification & Validation service, I am in charge of quality assurance for qualification activities (Equipments, Utilities, Facilities and HVAC) on a production unit revamping project.
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Pfizer
- Utilities Project Engineer, Engineering - Consultant for AKKA
Paris
2017 - 2018
Utilities project engineer within the engineering department from design to installation
- Definition of systems to be implemented in consultation with internal customers
- Detailled design and sizing
- Redaction of specifications and tender
- Tender phase and suppliers selection
- Redaction of Change Control
- Planning and budget follow-up
- Coordination and follow-up of construction works
- Writing and execution of validation documentation
- Update drawings and technical documentation
Project: modification of clean (new WFI loop, extension of Clean Steam and Process Compressed Air) and black (Industrial Compressed Air, black steam and condensates, chilled water, hot water, nitrogen…) utilities for new grade C areas
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Air Consult Engineering
- Project Engineer Clean Utilities and Equipments - Consultant for AKKA
2016 - 2017
Conducting feasibility studies, basic design and EPCMV (Engineering, Procurement, Construction Management, Validation) for different equipments and utilities in coordination with the client and other engineering office disciplines (black piping, HVAC, electricity, automation, architecture...)
- Definition of the requirement (URS redaction "User Requirements Specification" and tender)
- Sizing and selection of options
- Preparation and follow-up of the tender phase, cost estimation
- Vendor selection and documentation approval
- Coordination with customer and other disciplines for on-site installation
- Organization and following of legal receptions (PED, Machine Directive, Electricity)
- Realization and follow-up of the validation activities (FAT / SAT / IQOQ until hand over)
Equipments : autoclaves, degasser before a pure steam generator, CIP stations, washing machines, isolators / Utilities : WFI, LPW, PW, ACP
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GlaxoSmithKline
- Project Engineer Steam Sterilization, Engineering - Consultant for AKKA
Marly-le-Roi
2014 - 2015
Management of several projects related to installation or revamping of sterilization and decontamination autoclaves
Also in charge of continuous improvement projects and bringing help/expertise to GSK sites abroad concerning autoclaves
- Definition of need with users, sizing and options selection
- Preparation and following of tender phase with autoclave suppliers
- Design documentation approbation (P&ID, layout, alarm list, FS, HDS, SDS)
- Construction phase preparation with electricity, automation, finishes, piping interlocutors
- FAT at supplier factory
- Preparation and management of the commissioning tests in SAT
- Validation of the new equipment: redaction and execution of IQ (welding documentation, datasheets, P&ID walk-down...) / OQ (cycles optimization, thermal mappings...) / Alarms testing / Process control protocols : Back-up and Restore; Electronic Records and signatures (RERS)
- Hand-over of the equipment with users and maintenance for PQ
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GlaxoSmithKline
- Deviations and CAPA coordinator, MPU Formulation - Consultant for AKKA
Marly-le-Roi
2013 - 2013
In charge of deviations, CAPA (Corrective and Preventive Actions) and KPIs following
- Leader of investigation meetings and description according to the 5W2H method concerning process, logistics, environmental monitoring, validation, C&M, maintenance, automation, Quality Control or compliance deviations
- Choice of the right criticity level based on GMP impact, SQIPP (Safety, Quality, Identity, Potency, Purity) impacts and recurrence
- Root cause analysis: 6M (Man, Method, Material, Machine, Mother Nature, Mesure) or 5Why's
- Documentation of product, stability and validation impacts
- Management of CAPA related to deviations, AFMPS (BE) and FDA (U.S.) inspections
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UCB
- Process Engineer trainee, API pilot plant
COLOMBES
2012 - 2012
Preparation, execution and reporting of various tests or production GMP campaigns
- Scale-up of process in development from the laboratory to the pilot scale :
* Operators training, Process Safety Review (PSR), Process Sequence Diagram (PSD), Process Flow Diagram (PFD), redaction of manufacturing/cleaning protocols and campaign reports
* Equipments mainly used: reactors, filters, spin dryers, crystallizers… at pilot scale (500L - 3m3).
- Scale down from the production to the pilot plant
- Calculation of a global heat transfer coefficient from a crystallizer
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Sanofi
- Trainee, Process Development Chemistry Department
Paris
2011 - 2011
Study, test and optimization of a multi-steps synthesis of an API in a laboratory
