Senior / Staff Engineer, Technical Operations #3640

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
24 days ago