- 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
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Senior / Staff Engineer, Technical Operations #3640 - Raleigh, United States - GRAIL, LLC
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:
