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    Validation Engineer - Lansdale, United States - NavitsPartners

    NavitsPartners
    NavitsPartners Lansdale, United States

    3 weeks ago

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    Description
    Job Description

    Job Description


    Position:
    Validation Engineer - II


    Location:
    West Point, PA

    Duration: 12 Months


    Note:
    M-F/40hrs/week-100% onsite.


    Job Description:
    Candidate will work within the PCD metrology team that supports regulated equipment and systems used within a GxP regulated laboratories including robotics automation

    Primary focus will be participating in and driving computer system validation efforts associated with laboratory computerized systems, robotic automation, including LCMS systems, liquid handlers, plate readers/imagers, qPCR, flow cytometer, etc.


    Activities will include:
    Developing a working understanding of laboratory equipment and software applications validation
    Working with equipment vendors to appropriately setup system within a GxP environment
    Generating and/or updating system requirements
    Partnering with IT to establish system accounts and data flow pathways, with a focus on data integrity principles
    Partnering with document writers, IT, and Quality in the generation, review, and executing of system validation acceptance test documents
    Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities
    Support the purchase, install and equipment qualification of new laboratory equipment
    Partner with facilities staff on buildout of new labs or renovation of existing laboratories
    Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support
    Represent the laboratory on all aspects of laboratory equipment and system validation during audit
    Author SOPs associated with laboratory equipment or related processes
    Operate within the confines of departmental SOPs and regulatory guidance's
    Utilize electronic applications (Electronic Lab Notebooks, Procal, etc.) to input and retain calibration documentation

    System validation efforts may be for new system implementation, or part of change controls to upgrade or retire existing systems.

    Individual should have experience validating computerized systems within a regulated environment operating under SOPs and procedures.

    Qualification :
    B.S.

    Degree in the Biology, Biochemistry, Analytical Chemistry, Chemistry or related sciences with at least 3 years of industry experience or an M.S.

    with 1-2 years of related experience.
    Years of experience: 4+ (including experience validating LCMS systems; experience with Analyst application preferred).

    Site:
    Client West Point Campus and new campus located within 30 minute drive from west point campus. (on-site position 5 days a week during normal day time hours)

    Required Experience and Skill:
    Experience working within a GLP or GMP laboratory
    Deep expertise and experience handling computer system validations of laboratory systems
    Experience maintaining laboratory equipment including plate readers, automated liquid handlers, or other specialized computerized systems
    Capable of working independently under moderate supervision
    Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators

    #J-18808-Ljbffr
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