Senior / Staff Engineer, Technical Operations #3640

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

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