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Summary

after a first thorough experience of the processes and the production techniques of human immunoglobulins at pilot scale (technical services Laboratory), my evolution as a Validation Engineer allowed me to acquire new knowledge of commissionning / decommissioning and Qualification (iq, oq, pq) of full scale production equipments as well as the Qualification of processes with the coordination of the production of 1 batch of subcutaneous immunoglobulin. these experiences at pilot scale (in Laboratory) and at full scale (in production) associated with my University background in Biomedical Sciences specialized in Toxicology led me towards material Qualification Engineer position in which main responsibility is to qualify materials used in all the stages of production in agreement with the standards of countries being part of the business of the group. within these positions, i had the opportunity to familiarize with lean and Six Sigma tools, global harmonization, pharmacopeias, project coordination, GMP, multiple customers and supplier follow up and participate in numerous meetings and on the job trainings as well as Training in Statistics, ms office and global monitoring system.

Experiences

Current Experience

  • Principal Consultant


    Since June 2015

Past Experience

  • Global Material Qualification Engineer (Process Science and Technical Operation Dpt)

    August 2014 --- June 2015
    responsible for the Qualification of all materials used in baxter Manufacturing processes in Compliance with ph.eur, usp, jp, chp. (raw material, process component, intermediate, diluent, Packaging material, device, Chromatography resin) - evaluate impact and localisation of each material in the Manufacturing process. - perform and write Risk Assessment and material Qualification protocols - design and review extractable/leachable studies with internal and external stakeholders - drive conclusion matching toxicological assessment data and e/l data. - write report to release materials for their intended use in baxter Manufacturing process.

  • Material Qualification Engineer, Toxicology, material, quality, design, Extractable, Leachable

    February 2014 --- June 2015
    responsible for the Qualification of all materials used in the lessines plant Manufacturing process in Compliance with ph.eur, usp, jp, chp. (raw material, process component, intermediate, diluent, Packaging material, device, Chromatography resin) - evaluate impact and localisation of each material in the lessines Manufacturing process. - perform and write Risk Assessment and material Qualification protocols - design and review extractable/leachable studies with internal and external stakeholders - drive conclusion matching toxicological assessment data and e/l data. - write report to release materials for their intended use in lessines Manufacturing process.

  • Validation Engineer I - Bulk, Full scale, process, quality, qualification, equipments, clinical

    March 2013 --- March 2014
    main activities : perform Manufacturing process & equipment (re-)Qualification activities (including process, building & facilities, bulk, cleaning, hvac, utilities and shipping). prepare and implement the Validation Documentation required to assure the proper development of a project and support regulatory submissions. act as a Validation representative for projects provide support in all quality-related issues, including GMP/glp regulations, Compliance with internal SOP’s, and all aspects of safe, reliable and consistent operation of the system take part of internal/external audit to provide requested information. revision and approbation of the Change Control documents (dcr, forms related to cr, ni…) in term of quality representative. provide the required information to support the preparation of facility & process related files for the various regulatory agencies

  • Technical Services Technician, Pilot Scale, Process, Chromatography, immunology

    February 2012 --- March 2013
    study the impact of deviation and/or improvement within the Pharmaceutical Manufacturing process of baxter immunoglobulin drugs by producing immunoglobulin at Lab scale in the R&D technical services Laboratory using cutting edge Purification and separation technologies. evaluate the immunoglobulin content of all the process step to assess production yield. setting up new technologies to perform state of the art evaluation of production from Lab and manufacturing.

  • Master Thesis, Immunology, Toxicology

    September 2009 --- September 2011
    immuno-Toxicology : roles of myeloid derived suppressor cells in silica induced pulmonary fibrosis

  • Private Teacher of Science

    September 2010 --- June 2011
    provide science lesson to secondary school students in Physics

Personality

Self Assessment :
CoordinationProactivityAdaptabilityAttention to detailAssertivenessAnalytical thinkingCritical thinkingCuriosityIndependenceFlexibilityInterest in knowledgeReaction to stressCharmInnovative thinkingProblem solving

Knowledge

Self Assessment :
Study outcomes and outcome measures Labtechnician Lab scale batches Diabetes Cell biologyToxicology Scientific writingAntibodiesBiomarkersDrug metabolismScientific methodology Medical devicesProblem-solving methods and troubleshootingPilot scale batchesMolecular & Cellular BiologySafety concerns (such as therapeutic ratio with respect to possible adverse effects)Western BlottingLaboratory study designEnzyme-linked immunosorbent assay (ELISA)Endocrinology and metabolismPhases of clinical development (phase I to IV)Clinical research
LinkedIn Assessment :
sciencemolecular biologyGood Distribution Practice (GDP)Life SciencesImmunologyValidationPharmaceutical IndustryGMPGXPSOPAKTAPCRpharmacologyCell CultureFlow CytometryELISACell Based AssaysIn VivoIn VitroRNA isolationqPCRRT-PCRFluent EnglishToxicologyR&DChemistryGood Laboratory Practice (GLP)HPLCChromatographyBiopharmaceuticals

Skills and Expertise

Self Assessment :
Statistical analysisManage laboratory proceduresQuality control processcoordinating research projects Control data Interpret dataFollow-up of internal audits Report dataAdverse event reportingDesign studyDesign scientific projects (in biology)Organize scientific projects (in biology)Collaborate with medical team Analyze data

Education

  • Master of Science (M.Sc.) in Biomedical Science specialised in Toxicology from Université catholique de Louvain in 2011
  • Etudes Secondaires Générales in Math, Sciences from Collège Saint François Xavier 1 in 2004

Training and Certification

  • Lean Six Sigma Yellow Belt in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
Dutch
Elementary Proficiency

Work Preferences

  • Work From Home:
    Yes, 0 to 5 days per week
  • International:
    Yes

Area / Region

Waterloo, Belgique

Others

Driving License
  • No

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