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BioMérieux
- LIMS Deployment Lead
MARCY-L'ETOILE
2013 - maintenant
Lombard, IL, USA
Medical Devices, Prepared Culture Media
Coordinate deployment of LIMS (Laboratory Management Information System) software on bioMerieux pilot site :
-Manage project timeline,
-Operationally supervise team of 6 QC analysts,
-Coordinate data migration and change management streams on site,
-Participate in system testing and troubleshooting in coordination with global project team and software supplier.
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BioMérieux
- Sr Validation Engineer
MARCY-L'ETOILE
2011 - 2013
Lombard, IL, USA
Medical Devices, Prepared Culture Media
-Managed transfer of OEM FDA-regulated products from Portland, OR to Lombard, IL :
>>Coordination and implementation of new manufacturing, QC and shipping processes following customer specifications,
>>Performance of transfer risk assessment,
>>Writing of transfer documentation including transfer risk assessment and qualification protocols,
>>Supervision and participation in execution of validation activities for new clean rooms, new equipment and new process,
>>Personnel training to manufacturing process,
>>Implementation of new documentation.
-Drove Green Belt project for OEM product process optimization utilizing 6 Sigma and Lean methodologies : in-process scrap reduced by 50%, saved an annual USD 151k.
-Investigated product failures with application of corrective actions to process : lead investigator for NCMRs, non conformities and CAPAs for OEM products.
-Cultivated relationships hierarchically with operators and management, and transversally with all departments of the company as well as with suppliers and customers of OEM products.
-Conducted studies, wrote and executed validations for implementation of new equipment (sterilizers, filling machine), new processes (H2O2 decontamination) and for requalifications of existing equipment.
-Participated in site FDA readiness by updating validation master plan, improving validation practices, and standardizing manufacturing documentation for OEM products.
-Participated in internal and supplier audits.
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BioMérieux
- QA/Validation Engineer
MARCY-L'ETOILE
2009 - 2011
Wilsonville, OR, USA
Medical Devices, Prepared Culture Media
-Developed and maintained quality systems and programs in the areas of validation, calibration, maintenance, corrective and preventive actions to ensure compliance with FDA, customer and ISO 14385 requirements.
-Coordinated internal CAPA program, including leading cross-functional teams in Root Cause Analysis and writing investigation reports.
-Supervised validation activities for relocation of QC Laboratory on site and implementation of new vial filling line.
-Prepared OEM product transfer to Lombard site by performing gap assessment between manufacturing site and receiving site et evaluation of needs for raw material, equipment, environment, process.
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BioMérieux
- Validation Engineer
MARCY-L'ETOILE
2008 - 2009
Boxtel, Netherlands (11 months)
Shanghai, China (11 months)
Medical Devices, Immunoassays
In the context of immunoassays transfer from the Netherlands to China :
-Study of the process, analysis of equipment’s needs and specifications,
-Supplier follow-up in relation to equipment specifications,
-On new Chinese site :
>>Implementation of validation plan including building, utilities and equipment (clean rooms, DI water, pure steam, dry air, thermostatic chambers, autoclaves, freeze dryer, ultrasonic bath, hoods, QC instrumentation, Building Monitoring System, vial filling and capping line, specific equipment related to EIA process)
>>Management of validation planning :
--Writing of validation documentation (validation plans, risk assessments, validation protocols for IQ, OQ, PQ and reports) in compliance with Chinese GMP and ISO regulation,
--Staff training to validation ,
--Supervision of tests execution,
--Approval of validation protocols,
--Follow-up of anomalies and implementation of action plans with Quality Assurance.
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Sibert SA
- Quality Engineer
2006 - 2008
Loyettes, France
Produits Frais/Charcuterie
-Performed application, including the following of quality indicators,
-Conducted training of operators to good manufacturing practices
-Coordinated implementation of IFS (International Food Standard), including formalization and harmonization of documentation system, implementation of processus approach per ISO 9001:2002, update of HACCP assessment and implementation of mitigation actions on process,
-Implemented and followed quality indicators.
