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    Production Operator - Janesville, United States - Shine Technologies Corp

    Shine Technologies Corp
    Shine Technologies Corp Janesville, United States

    1 week ago

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    Description

    Job Type

    Full-time

    Description

    SHINE Technologies is immediately seeking a 2nd Shift Production Operator - cGMP to perform production of medical radioisotopes and grow our manufacturing processes in Janesville, WI. The Production Operator will perform operations using remote manipulators in cleanrooms to produce Lu-177, and perform other production tasks including receiving raw materials, processing radioisotopes in production hot cells, preparing the sterile API and shipping the API to our customers. This is an amazing opportunity for someone with a diverse background to join our team and help build our manufacturing operations as we start with clinical production and grow into commercial production. A strong background in pharmaceuticals/APIs or medical devices is required and work with radiopharmaceuticals is preferred. This is a strong team environment, and our operators must work well between all departments. This is a fast-paced product development cycle to help cure some life-threatening forms of cancer and we are looking for team members that fit well into this environment.

    Duties and Responsibilities:

    Specific duties and responsibilities of the Production Operator include, but are not limited to:

    • Operate, maintain, and report process data from automated and semi-automated radiopharmaceutical manufacturing equipment to produce cGMP products.
    • Prepare materials/consumables for manufacturing processes and perform cleaning activities, line clearances, and system checks on equipment before use in aseptic processes.
    • Create documentation as required for manufacturing drug products.
    • Follow and observe all radiation safety and pharmaceutical requirements.
    • Receive raw materials and package manufactured drug product for shipment.
    • Assist other projects and departments and perform other duties as requested or assigned.
    • The position will require non-standard work hours and shift work, on a periodic, rotational or ongoing basis.
    • Some travel may be required.
    • Overtime may sometimes be necessary to complete required work assignment with little or no advance notice.
    Requirements
    • Degree in engineering or scientific discipline or comparable experience
    • Minimum 2 years of equivalent experience
    • Pharmaceutical or API manufacturing experience required
    • Knowledge of cGMP requirements, aseptic process (cleanrooms environment), and equipment qualification preferred
    • Radioisotope production experience preferred
    • Efficient in the use of MS Office Suite required
    • Willingness to learn and understand new technology, instrumentation and technical processes
    • Ability to read from engineering drawings or schematics
    • Ability to follow written procedures and accurately record test data
    • Ability to work safely within an industrial and radiation environment
    • Ability to work multiple or staggered shifts required
    • Able to lift up to 50 lbs.
    Eligibility for employment is conditioned on the applicant's ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant's eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.

    SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

    SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

    Pay Transparency Policy

    Employee Rights Under the NLRA

    Equal Opportunity Employment

    E-Verify
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