Dynavax Technologies

  • Manufacturing Process Expert (m/f/d)

    Job Locations DE-NW-Düsseldorf
    Job Post Information* : Posted Date 1 week ago(7/11/2018 6:23 PM)
    Req. #
    HP-229
    # of Openings
    1
    Category
    Manufacturing
  • MAJOR DUTIES OF POSITION

    • Responsible for timely processing of Quality Documents related to the manufacturing of the Hepatitis B Drug Substance (Deviations, Change Control, CAPA’s, OOS) in close collaboration with other departments (QA, Engineering, QC, Tech Ops support) 
    • Preparation and processing of failure investigation reports 
    • Support the definition of Corrective Actions/Preventive Actions 
    • Execute and track change control requests; participate in change control meetings 
    • Make sure defined measures are executed in time; compile relevant statistics (KPIs) 
    • Interview Manufacturing Operators as part of the failure investigation procedure 
    • Create, Manage and Support continuous improvement projects 
    • Become a subject matter expert in the manufacturing process (quick learner) 
    • Prepare technical reports and root cause investigations in a clear and concise manner (good English writing skills)

    KNOWLEDGE AND SKILL REQUIREMENTS

    • Degree in Life-sciences (e.g. Biotechnology, engineering, biology, chemistry) – or similar qualification combined with in-depth work experience 
    • 3+ years of experience in the Manufacturing of pharmaceuticals, ideally Biopharmaceuticals/aseptic Manufacturing
    • Strong competency in root cause investigational tools and data analysis
    • Strong communication skills (written and verbal)
    • Ability to train others on complex processes 
    • Thorough knowledge of manufacturing plants and clean rooms 
    • Comprehensive GMP Skills and Knowledge of pharmaceutical standard regulations (EU GMP Guidelines, CFR, AMWVH etc..) 
    • Experience in deviation and change management 
    • Excellent problem-solving skills, good communicator, strong analytical thinking with excellent documentation skills 
    • Very good English language skills 
    • Experience in Project Management a plus 
    • A yellow or green Belt would be preferable

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