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    Process Engineer - Chicago, United States - US Tech Solutions

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    Description

    Key Responsibilities:

    • Experiences, knowledge, skill sets, and scientific training in
    lyophilization in freeze-drying

    and other related

    manufacturing processes

    to support multiple projects toa) advance

    process development

    of pharmaceutical drug products andb) explore

    process robustness

    from

    lab and pilot to manufacturing scales ,c)

    characterize and compare the drug products from different manufacturing processes

    andd) partner with the project team members and subject matter of experts to deliver project goals timely with high quality.


    These include:
    Lyophilization Manufacturing Process

    of Pharmaceutical Products

    • Support the lab experimental of
    freeze-dry


    and other related manufacturing processes, and conduct the lab experiment, analyzed collected data, summarize observations and present slide decks to stakeholders.


    • Support the
    scale up of manufacturing process from lab, pilot to commercial scales


    with cycle developments of various process conditions and cycles for multiple drug products to enhance product quality and improve manufacturability.


    • Perform engineering analysis by using
    heat and mass transfer for the lyophilization process

    and other related manufacturing processes with experiences in different

    freeze-dryers

    and support analytical techniques.

    • Analyze the processing and analytical outcome and provides scientific explanation and justification of results based on the generated data from modeling and analysis.
    • Characterize the products by multiple analytical instruments to develop the material – equipment – process – performance relationship.
    • Partners with team members to ensure all objectives are met; supports team to design and
    develop freeze-drying process

    of the critical process wetting and product parameters.

    • Prepare study design and provides written, verbal deliverables, reports and presentations for management and stakeholder reviews during the progress and at the project final conclusion.
    • Participate in various scientific and technical presentations, discussion, and communication; summarize key observation to support the project team for decision making.
    • Practice and be aware of the potential consequences (defects and failure modes) of design changes to established processes. Mitigate risk within functions through sound design, early risk assessments and implementation of fallback strategies.
    • Identify, plan, and conduct medium- to large-size projects across engineering disciplines requiring custom, risk-managed execution plans, investigations, and/or equipment. Make tough decisions regarding priorities between projects.

    Expected Qualifications:

    • Education/degree in
    Ph.
    D. or M.S. with lyophilization and related manufacturing processes

    experience and academic training is preferred and may contribute towards the desired years of experience.

    • Training at scientific graduate / postgraduate degree in chemical engineering, aeronautics and astronautics engineering, materials science and engineering, mathematical engineering, biomedical engineering, pharmaceutical sciences, physical chemistry, or other relevant degrees.
    • Experience and knowledge in
    lyophilization manufacturing process

    and its related

    heat transfer (conduction, convection and radiation), mass transfer and momentum transfer

    of unit operations for scientific problem solving and its associated materials knowledge of the subjects of applications.

    • Experience and knowledge in
    process control and monitoring of lyophilization temperature

    and pressure of

    drug product manufacturing

    and advancing in process control and monitoring for continuous improvements.
    #J-18808-Ljbffr

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