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    Validation Engineer - Sterling, United States - Premier Life Sciences LLC

    Premier Life Sciences LLC
    Premier Life Sciences LLC Sterling, United States

    1 week ago

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    Description
    Not for C2C Candidates Please

    Role:
    All Validation Engineer (V&V, CQV, CSV, Equipment, Process)

    Location:
    Country Wide USA

    Duration: 12+ months + extensions

    Visa{ USC, GC, H4 OPT CPT


    Job Description:
    Process and equipment qualification (IQ/OQ/PQ).
    Development of test methods for Design V&V, Process Validation, and Production
    Validation of test methods
    Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
    Authoring/releasing of new test methods and editing/redlining of old test methods

    The education/experience I am looking for is as follows:

    This position requires a Bachelor of Science in Engineering or combination of relevant education and experience as well as 5 years relevant experience in medical device manufacturing.

    Expertise in medical device manufacturing and with strong working knowledge of cGMPs.
    Clean room environment experience
    Manufacturing Engineering and automation experience.
    Experience with Test Method Validation and/or Measurement System Analysis is preferred.

    Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.

    Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
    Strong organizational skills, detail oriented.
    Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
    Ability to work to a deadline and to handle multiple tasks simultaneously.
    Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.

    #J-18808-Ljbffr
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