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Jonas PETIGNAT

Paris

En résumé

Mes compétences :
Chimie
Qualité
Ingénierie
Gestion de projet
Validation

Entreprises

  • Celgene International Sàrl - Senior Validation Engineer

    Paris 2012 - maintenant As Senior Engineer, I am responsible for managing validation projects. As a key member of the Validation Services team, I regularly work cross functionally with Manufacturing, QA, Logistics, Facilities, Drug Product Development and Vendors.

    -Subject Matter Expert for Cleaning Validation and Utilities Qualification.
    -Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their life-cycle.
    -Author and when required review validation documents, including requirement specifications,
    validation plans, protocols, reports, traceability matrix and summary reports
    -Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation.
    -Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes.
    -Participate to the development and maintenance of the local site procedures
    -Lead risk assessments when required. Participate to risk assessments & risk management teams.
    -Review change control documents, to evaluate impact on qualified systems and validated processes
    -Manage validation projects; including managing time, resources and budgets
    -Develop and justify the validation approach based on risk and a scientific rational
    -Co-ordinate qualification and validation execution activities, including external vendors and
    internal departments
    -Maintain procedures governing validation to ensure they are in compliance with Corporate
    policies and regulatory requirements
    -Participate when required during internal and external audits for which they are a SME, by
    answering questions, reviewing qualifications and validations with auditors, and providing documentation
    -Establish and maintain effective relationships with internal team, customers and suppliers
    -Provide mentoring and leadership to Validation Services team
  • Celgene - CAS Validation Engineer

    Paris 2008 - 2012 Gestion et validation du système automatisé de fabrication
  • Ecole d'Ingénieurs de Fribourg - Ingénieur R&D

    2006 - 2008 -Création d'une plateforme de réaction basée sur les microréacteurs
    -Etude de réactions chimiques complexes
    -Optimisation de synthèses grâce aux microréacteurs
    -Gestion de projet en nanotechnologie
    -Responsable de cours pour apprentis de langue allemande
    -Remplacement en cours et au laboratoire
  • DuPont SA - Diplômant

    2006 - 2006 Optimisation et étude de risque sur un des procédés de production de la firme DuPont Polymers Powder Sàrl.

Formations

  • Ecole D'Ingénieurs De Fribourg Section de Chimie (Fribourg)

    Fribourg 2003 - 2006 Génie chimique
  • EPSIC (Lausanne)

    Lausanne 2000 - 2003 chimie

    Chimie

Réseau

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