Engineer Mfg Science Drug Substance USP

vor 4 Wochen

Bern, Schweiz Randstad (Schweiz) AG, co Johnson & Johnson Vollzeit
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Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 120,000 people.

Johnson & Johnson Innovative Medicine is a global pharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 600 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and bacterial based therapeutic products.

The aim of the position is to support a new CAR-T Technology Transfer into GMP manufacturing process with focus as SME for Upstream process steps (mammalian cell culture cultivation in shake flasks and bioreactor systems).

Main Responsibilities

  • Perform Technology Transfer of a new process into GMP Manufacturing (writing of Process relevant documents like Process Description, MBR's (first draft), Work Instructions etc
  • Training of Operators on new / written documents
  • Writing of Reports (TechTransfer/Campaign), Technical documents like Risk Assessments / Technical Assessments
  • Help in troubleshooting and process improvements
  • Perform GEMBA walks in the Manufacturing suites
  • Managing of Quality Issues, Root Cause Analysis and Investigation
  • Data verification
  • Data trending
  • Initiating and implementing of Change Controls
    Functie-eisen

    Who we are looking for

    • University degree in Bio-Engineering / Biotechnology / Biology / Biochemistry
    • Experience in GMP compliant biotechnological manufacturing or development
    • Experience with mammalian cell cultivation
    • Excellent problem solving and analytical capabilities
    • Knowledge in Statistic
    • Team player and a personality with excellent interpersonal communication skills
    • Capacity to communicate fluently in English and German

      This job based in Bern, Switzerland will initially be limited to 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, inclusive, and collaborative environment, then send us your application today. Or give us a call if you have any questionsStephan Zoebeli

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