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Senior / Staff Engineer, Technical Operations - Raleigh, United States - GRAIL, Inc.
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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 teamDevelop 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 projectsIndependently 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 workflowsEnsure 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 equivalent6+ years of Automation-related experience2+ years of experience in the development or support of Next Generation Sequencing assays and workflowExperience working in a regulated environment under CAP/CLIA and/or FDA, including documentation, change management/control, and non-conformance programsExpertise in manufacturing or automation of clinical diagnostics, medical devices, or equivalentDemonstrated Technical leadership, self-direction, and willingness to teach others and learn new techniques.
Good planning, prioritization, problem-solving, and organizational skillsData analysis using tools such as JMP, or proficiency with R or PythonEffective written and verbal communication skills (fluency in English) as well as strong interpersonal, negotiation, and influencing skillsExperience with GSuite, Jira, and/or Confluence