Werner Hummelman-Schalk

Sterilization Validation Engineer at Janssen Pharmaceuticals

Zundert, North Brabant, Netherlands

About

I am a sterilization validation engineer and SME for thermal validations in the pharmaceutical industry, currently growing into an Subject Matter Expert role on aseptic process simulations and dynamic airflow studies. I have a Master of Science degree in Biomedical Engineering and I have 1.5 years of experience as a researcher in the natural textile dyes industry. For 5.5 years I performed different roles as a consultant within the medical device and pharmaceutical industry (complaint handling, combination products and sterlization validation). People describe me as a hardworking employee with attention to detail. I enjoy working in a team but I am also able to work independently. I am eager to learn and improve my knowledge on sterilization processes in the pharmaceutical industry.

Experience

  • Sterilization Validation Engineer at The Janssen Pharmaceutical Companies of Johnson & Johnson
    Mar 2022 - Present · 4 yrs 4 mos

    Subject Matter Expert Thermal Validations Responsible for the coordination and execution of sterilization (re)validations of lab and production equipment

  • Capgemini Engineering (5 yrs 7 mos)
    • Senior Consultant/Engineer Life Science
      Sep 2021 - Mar 2022 · 7 mos

    • The Hub for Life Sciences SPOC NL
      Aug 2020 - Mar 2022 · 1 yr 8 mos

      Capgemini Engineering Netherlands Single Point of Contact for The Hub for Life Sciences, a unique platform uniting life sciences experts that connects more than 2500 consultants in all Capgemini Engineering geographies

    • Cleaning Validation Engineer @ Janssen Pharmaceuticals
      May 2020 - Mar 2022 · 1 yr 11 mos

      Supporting cleaning validation activities

  • Quality Employee at Rhenus Contract Logistics
    Jul 2016 - Aug 2016 · 2 mos

    Document control of procedures concerning the manufacturing and repair of Portable Oxygen Concentrators of InovaLabs. Checking the differences between Work Instructions and performed actions during repair. Writing recommendations for improvement of Work Instructions.

  • Researcher at Rubia Natural Colours
    Sep 2014 - Jan 2016 · 1 yr 5 mos

    Design and perform experiments to improve the wash, rub and light fastness of natural dyes on wool and cotton. Supervising student interns.

  • Warehouse Employee at HON/TechData
    Nov 2013 - Aug 2014 · 10 mos

    Working here via employment agency Tempo-Team Tasks: Packing using MLSPro and Picking & Packing using SAP