Project Manager, Pharma Equipment Validation - Raleigh, United States - Frankel Staffing Partners

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    Description
    Our client, a highly successful RTP area firm that provides

    consulting services to pharmaceutical companies

    worldwide, is actively recruiting a top-notch candidate to join its client services team.

    These are

    project management roles . The firm is engaged by its clients to

    lead high-impact, high-cost initiatives

    such as

    major buildouts, capital improvements, operations excellence

    programs, etc. Consultants are embedded into the client's organization and

    drive the execution of these projects .

    These are challenging roles. Consultants take over the day-to-day management of the projects, and we seek candidates who are

    take-charge, get-things-done

    leaders but also hands-on, adaptable, and resourceful team players.


    Key Things to Note:

    • For their initial engagement this Consultant will
    work with an RTP, NC area client

    that is building out a $2 billion pharma biomanufacturing facility. This is a cell culture CDMO.
    o As part of the process,

    all equipment must be validated .
    · There are 100s of pieces of equipment across multiple buildings.
    · It is an enormous challenge that must be meticulously planned out and managed.
    o The firm will work in partnership with client leadership to plan the

    timetable, scope, testing/validation strategies, resources, materials,

    assigned parties, etc.
    o Consultant will

    drive the project based on the action plan .

    • This Consultant will begin by
    managing the validation efforts for all Downstream equipment


    including:
    o Chromatography Columns – Packing, running, and cleaning a column
    o Centrifuges
    o Buffer preparation and tanks
    o Virus filtration and others
    Seek candidate who has

    worked with

    downstream processing

    equipment. Engineering background would be a plus. Familiarity with

    CQV strategies

    would also be valuable.

    • This Consultant will
    bring technical know-how

    to the project and be responsible for

    keeping the initiative on track .
    o This will involve providing direction to all stakeholders, monitoring progress, troubleshooting issues, and maintaining and communicating records of progress.
    o This will also involve


    ensuring that all materials and participants are available as needed , based on the timetables set, and adjusted for any revisions.

    We seek candidates whose technical bkgd is complemented by the

    ability to manage complex and dynamic projects.

    • The
    firm uses Excel

    and MS Project to track and report on many aspects of activity. Advanced Excel skill is required. MS Project would be a plus.

    • This is a
    highly collaborative

    role.

    This PM will regularly interface with a wide range of internal and external stakeholders to ensure all aspects of the project are properly understood and executed.

    We seek a superb communicator.

    • This position
    is

    located in Holly Springs, NC.

    Targeted candidate will offer a

    BA/BS degree in a technical field and 2+ years

    working with the equipment types noted above. Some familiarity with CQV processes will be important.

    In addition, we seek a candidate with the demonstrated ability to

    manage projects by coordinating

    the resources, timelines, and people needed to achieve a shared goal.

    Finally,

    Consultants represent the firm . They are the face, eyes, and ears of the firm on a daily basis. We seek super smart, industrious, and professional candidates who have an

    enormous desire to learn, achieve, and have impact .

    This is a Direct Hire opportunity and an immediate need.

    Please forward resume for prompt consideration. Local candidates targeted.

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