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    Systems Engineer II - Raleigh, United States - GRAIL, Inc.

    GRAIL, Inc.
    GRAIL, Inc. Raleigh, United States

    3 weeks ago

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    Description

    GGRAIL is seeking a Systems Engineer II for the Engineering Operations team for all possible shifts. As an Systems Engineer II, you will provide site-wide support for clinical and non-clinical operations activities while implementing global solutions. Responsibilities will include the aspects of GRAIL's asset lifecycle program including installation, maintenance, and performance of cutting-edge laboratory equipment and software applications and may include preventive, predictive, corrective, projects, qualification, etc. along with documenting activities in accordance with regulatory compliance guidelines. Supporting laboratory equipment will range widely but will include next-generation sequencing platforms and automated liquid handling robots. This position will be working in close collaboration with the clinical and non-clinical lab staff and multi-functional teams. Strong interpersonal and troubleshooting skills are essential for success in this position.

    This is a full time, onsite position working in the Research Triangle Park, NC lab.

    1st Shift Start Time: 8:00am EST
    2nd Shift Start Time: 4:00pm EST
    3rd Shift Start Time: 12:00am EST

    Work on holidays may be required

    Working hours may be temporarily adjusted due to business needs, training, travel, and other events.
    Responsibilities;

    • Perform troubleshooting, recovery, debugging, and repairs on laboratory systems and equipment in a regulated environment
    • Execute Equipment Lifecycle Management processes and procedures by supporting and maintaining equipment records for traceability purposes in compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 / 15189 requirements, and the GRAIL QMS (Quality Management System)
    • Support and improve embedded equipment software method management and virtual machine management processes.
    • Reduce and improve unplanned maintenance wherever feasible, assuring efficient and productive operation of equipment. Prolong the economic life of assets at the lowest practical cost.
    • Support engineered solutions to mitigate repetitive failures that adversely affect plant availability, performance, capacity, quality, cost, or regulatory compliance
    • Update: procedures, work instructions, guidelines, and testing documents such as installation / operational / verifications, standard operating procedures (SOP)
    • Manage and source vendors to support qualifications, installations, calibrations, investigations, upgrades, preventive maintenance (PM), and/or repairs as needed
    • Document and transfer knowledge to fellow engineers and laboratory operators
    • Support the investigations in NCRs, CAPAs, and associated quality and technical investigations
    Preferred Qualifications;
    • 2+ years experience using an asset computerized maintenance management system (CMMS)
    • 2+ years experience writing and executing windows based scripting language(s).
    • 2+ years experience troubleshooting and understanding the relationship between computer systems, hardware, software, networks, and telecommunications for storing, retrieving, transmitting, and manipulating data.
    • 1+ years experience in cross-functional project management and implementing new workflow processes.
    • 1 + years experience with data analysis techniques including statistical process control, OEE, reliability modeling and prediction, RCA techniques, and/or sig sigma methodology
    Required Skills;
    • 2+ years of related experience with a BS/BA or higher degree in Engineering of equivalent work experience.
    • 2+ years experience maintaining and writing/optimizing methods on automated liquid handling systems (e.g. MultiFlo/Bravo, STAR/STARlet, Echo, Lynx, Lunatic, high throughput NGS sequencers)
    • 2+ years experience of technical writing within a regulated environment
    • 2+ years experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems (MES), Customer Relationship Management (CRM) software
    • 1+ years experience developing Powershell scripts for automation and windows-based environment solutions
    Required Education;
    • Bachelor's degree or equivalent in Engineering, Physics, Chemistry, or similar Life Sciences discipline. Engineering degree preferred
    Physical Demands & Working Environment;
    • Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, and wear safety gear.
    • Hours and days may vary depending on operational needs.
    • Working with dry ice may be necessary.
    • Standing or sitting for long periods of time may be necessary.
    • May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.
    • Must occasionally lift and / or move up to 10 pounds.
    • Must occasionally lift and/or move up to 25 pounds.
    • Must occasionally lift and/or move up to 50 pounds.
    • Travel may be required, up to 10% of the time.
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