• IVF Media Scientist - Engineer

    Requisition ID
    2019-5822
    # of Openings
    1
    Job Location(s)
    Eight Mile Plains QL Australia
    Position Type
    Full Time
    Expiry Date
    9-2-2019
    Category
    Engineering
  • Overview

    Global Medical Device Manufacturer

    We are committed to patients and quality products

    Access to generous employee benefits

     

    COOK Medical, a global organisation in interventional medicine, has sales, marketing and manufacturing offices worldwide. COOK is at the forefront of medical research and product development in minimally invasive health care devices.

    We are seeking an experienced IVF Media Scientist / Engineer on a contract basis working full time for up to 2 years. This role is responsible for supporting the production transfer of IVF Media through the generation of quality, manufacturing and procedural documentation.

    Responsibilities

    • Generate and review design control documentation for design changes during transfer project
    • Review and/or generate protocols and reports for Equipment Installation, Operational and Performance Qualification.
    • Generate and review manufacturing instructions and SOPs
    • Maintain accurate records describing cleanroom zones, utilities, critical equipment and process flow at contract manufacturer
    • Interface with key stakeholder groups such as Quality Assurance, Regulatory Assurance, Validation Engineering and Manufacturing
    • Perform feasibility studies to evaluate new processes, equipment and raw materials
    • Review and generate test method validation protocols and reports
    • Perform all tasks in accordance with the Quality Management System to a competent standard
    • Review procedures for compliance with relevant standards for aseptic processing and sterilization of medical devices

    Qualifications

    • Degree in a Science or Engineering field of study essential
    • Knowledge and experience within regulated manufacturing industries working to GMP standards essential
    • Knowledge or proficiency in commissioning, qualification, procedure generation and change control essential
    • Knowledge and understanding of GMPs, industry guidance, and aseptic techniques desirable
    • Experience working with the medical device manufacturing industry highly regarded
    • Understanding of statistical analysis tools and methods desirable

     

     

    The future of medical care has never been more exciting.

     

     

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