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Willy MekezeWM

Willy Mekeze

Bioprocess / Qualification Validation

€400/day
Paris, FR
3-7 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Willy

Graduated in biochemistry and biotechnology process engineering, I am passionate about bioproduction. I have acquired numerous and solid skills related to the biopharmaceutical sector, particularly in qualification/validation during my various missions on projects such as the Merial/Boehringer Ingelheim Antaras project or the SANOFI EVF-Utility project. I remain open to all missions related to the bioproduction sector (Upstream, Downstream, Qualification / validation, extrapolation...).
  • French

    Native or bilingual

  • English

    Conversational

Can work on-site
Paris (up to 50km), Bordeaux (up to 100km), Lille (up to 100km), Toulouse (up to 100km), Paris (up to 100km)

Experience

  • GIANT
    Validation Qualification Engineer
    PHARMACEUTICALS INDUSTRY
    January 2025 - August 2025 (7 months)
    Commissioning and qualification of a purified water production unit on a pharmaceutical site undergoing expansion.
    Functional Analysis PID control Document Management deviation and change management purified water production
  • stallergene greer
    Process Validation Engineer
    PHARMACEUTICALS INDUSTRY
    January 2024 - December 2024 (11 months)
    Antony, France
    Stallergene Greer is a pharmaceutical laboratory that treats allergies through desensitization. I am part of the development and production support department. My tasks include process validation, process optimization, statistical studies using JMP, CAPA management, change control, deviations...
    CQV (Commissioning Qualification and Validation) change control, CAPA, and deviation management upstream and downstream process document management (protocol, report, VMP, risk analysis, criticality analysis) data analysis (JMP SAS, SAP, LIMS) and ERP (SAP S/4HANA)
  • Boehringer Ingelheim France
    Production Assistant
    PHARMACEUTICALS INDUSTRY
    February 2022 - August 2022 (6 months)
    Jonage, France
    - Writing regulatory documents "Blueprint legend" for the USDA: description of the production process, description of CTAs, description of contamination prevention procedures (cross-contamination, microbiological and particulate), and disinfection.
    - Inventory of all site equipment
    - User review of ultrafilters: control of PIDs, isometric drawings, and functional analysis, physical control of equipment (dead leg, slope...)
    - Control of bag filters
    - Leak testing
    - Configure and optimize process lines
    - Writing protocols
    - Rationalization of leak tests for process lines in the DSP workshop
    - Training operators on leak tests.
    - Helium testing
    - Execution of static SAT (insulation, welding, premises)
    - Participation in the user review of ultrafilters
    - Training received: GMP, HSE, SAT, CTA, data integrity, clean room and aseptic techniques, ultrafiltration, cell culture
    GMP ultrafiltration /diafiltration sterilization and cleaning in place technical documentation (P&ID, Isometric, PFD, functional logic, grafcet) purification process

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Education

  • Master's degree in Process Engineering Applied to Biotechnology
    CPE Lyon
    2022
    BPF/GMP, culture cellulaire, fermentation, bioréacteur,ultrafiltration / diafiltration, chromatographie, filtration , centrifugation, dimensionnent, cristallisation, extrapolation/intrapolation, qualification validation (PDV, URS, QC, QI, QO, QP, analyse de criticité, analyse de risque), stérilisation, salle blanche et CTA, plans d’expériences, QBD, PAT
  • Master's degree in Process Engineering
    ENSAI
    2019

Skill set (52)

Categories

  • Other