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    Facility Engineer - Horsham, United States - PAREXEL

    PAREXEL
    PAREXEL Horsham, United States

    3 weeks ago

    PAREXEL background
    Description


    We are looking to fill a Facility Engineer - Suite Coordinator position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA.

    This position offers full benefits, sick time, 401K, paid holidays, and paid time off.
    Description

    The Facility Engineer - Suite Coordinator supports facility readiness and compliance in support of pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies.

    Responsibilities

    Primary functional responsibility is the independent execution of processing suite maintenance activities within the policies and procedures of the client, while maintaining the highest level of proficiency in the responsibilities required of cGMP processing areas.

    Develop expertise in all primary job functions, enabling the ability to train others and update SOPs as required.

    Foster a customer service attitude within and among facility, equipment, and process operations personnel.

    Ensure work is documented in compliance with the ALCOA principles of data integrity, cGMPs, GLPs, and departmental procedures

    Complete assigned suite maintenance activities within the timeframes required by departmental and site procedures

    As required collaborate with team members to ensure completion of all Infrastructure Engineer tasks.

    This may include but is not limited to the following:
    processing material transfer requests and facility coordination actions.

    Author/Revise GMP Documentation (e.g., Standard Operating Procedures (SOPs))

    As required, prepare and execute investigations and change control records across various quality production systems.

    Qualifications
    Bachelor's degree in Engineering, Biology, Chemistry, Biochemistry, or a related scientific field, with 0 to 2 years of experience

    Required Skills and Experience
    Individual must be able to gown to meet cGMP or safety requirements (e.g., aseptic gowning or live virus/BSL-2 gowning)

    Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment

    Demonstrated critical thinking skills, and problem solving

    Strong written and verbal communication skills

    Desired Skills and Experience
    Mechanical aptitude

    Working knowledge of cGMP requirements

    Demonstrated ability to manage multiple tasks and priorities

    About Parexel
    Parexel FSP includes the CMC Operations group.

    We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

    For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

    Come join us

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