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Arvada

    Lab Validation Technician - West Point, United States - NavitsPartners

    NavitsPartners
    NavitsPartners West Point, United States

    3 weeks ago

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    Description

    Position: Lab Validation Analyst
    Location: West Point, PA 19486
    Duration: 12 months

    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, and 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 application validation
    • Working with equipment vendors to appropriately set up systems 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 execution of system validation acceptance test documents
    • Gain a working knowledge of laboratory equipment to facilitate troubleshooting and/or perform maintenance or calibration activities
    • Support the purchase, installation, and equipment qualification of new laboratory equipment
    • Partner with facilities staff on the 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 the audit
    • Author SOPs associated with laboratory equipment or related processes
    • Operate within the confines of departmental SOPs and regulatory guidance
    • 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.
    • Individuals should have experience validating computerized systems within a regulated environment operating under SOPs and procedures.

    Qualification:

    • B.S. Degree in 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).

    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
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