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    Senior / Staff Engineer, Technical Operations - Raleigh, United States - GRAIL, Inc.

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

    3 weeks ago

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    Description

    GRAIL is seeking a Sr. Engineer in Technical Operations in our Menlo Park facility. The ideal candidate is a team player with hands-on experience developing and implementing validation plans for laboratory and/or manufacturing equipment and a willingness to lead and teach others. The candidate will be encouraged to think outside of the box to creatively solve problems related to the management and execution of NGS-based workflows. They will work collaboratively across organizational functions and execute experiments individually and as a team. The candidate will be instrumental in implementing process improvements, developing documentation, and carrying out verification and support functions for operations within GRAIL laboratories.
    Responsibilities:

    • Act as the Technical Operations SME for equipment, equipment performance specifications, and processes in use by the Lab Operations team
    • Develop expertise in automation, software, performance data, and specifications related to instrumentation, equipment, and consumables used in the execution of Grail's commercial assay(s)
    • Coordinate across Technical Operations to develop and execute business programs supporting Verification/Validation, Improvements, and Investigations.
    • Serve as the primary project coordinator for Technical Operations automation improvements at the MPK facility, coordinating with the RTP site.
    • Contribute to quality, optimization, and technology transfer projects
    • Independently design, conduct and analyze data from experiments to support automated NGS-based assays.
    • Lead and contribute to investigation teams in troubleshooting and root cause analysis across operational functions and workflows
    • Ensure laboratory activities are performed and documented following regulatory and study requirements (GLPSOW/CAP/CLIA/FDA)
    Preferred qualifications:
    • Minimum of B.Sc/M.S. in BioEngineering, Molecular Biology, Biochemistry, Automation Engineering, or a related field or equivalent
    • 6+ years of Automation-related experience
    • 2+ years of experience in the development or support of Next Generation Sequencing assays and workflow
    • Experience working in a regulated environment under CAP/CLIA and/or FDA, including documentation, change management/control, and non-conformance programs
    • Expertise in manufacturing or automation of clinical diagnostics, medical devices, or equivalent
    • Demonstrated Technical leadership, self-direction, and willingness to teach others and learn new techniques.
    • Good planning, prioritization, problem-solving, and organizational skills
    • Data analysis using tools such as JMP, or proficiency with R or Python
    • Effective written and verbal communication skills (fluency in English) as well as strong interpersonal, negotiation, and influencing skills
    • Experience with GSuite, Jira, and/or Confluence
    The expected, full-time, annual base pay scale for this position is$127,000 - $159,000. Actual base pay will consider skills, experience, and location.
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