GRAIL is seeking an Operations Engineer 1 for the Engineering Operations team for the 3rd shift (10pm to 6:30 am). The Operations Engineer 1 will support, coordinate, and provide technical engineering expertise for a variety of processes, automation hardware systems, software applications, and laboratory equipment and systems. The Operations Engineer 1 will primarily interact with clinical operations, research scientists, automation developers, and software teams to ensure smooth performance of a complex platform. This includes both supporting day to day triage of production support issues that arise, and working to continuously improve our systems by helping gather requirements and prioritize improvements. GRAIL’s testing volumes are scaling fast and require a dynamic and detail-oriented engineer to help deliver our revolutionary test to as many people as possible.

This is a full time, onsite position working in the Research Triangle Park, NC lab between the hours of 10:00 PM to 6:30 AM.

Positions are 10 hour shifts, 4 days a week. Positions are available for Sunday through Wednesday and Wednesday through Saturday.

Working hours may be temporarily adjusted due to training, travel, and other events.

Responsibilities;

• Perform on-site troubleshooting, recovery, debugging, repairs, and routine and non-routine maintenance of laboratory equipment, hardware, and systems.
• Perform live troubleshooting, recovery, debugging, repairs, and equipment and systems maintenance to keep assets in good working order.
• Maintain equipment lifecycle records in our Asset Management System for traceability and perform all work in compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 / 15189 requirements, and the GRAIL QMS (Quality Management System).
• Revise, update, and execute, test plans, IOPQ protocols, site acceptance testing (SAT), verifications, and standard operating procedures (SOPs) as needed.
• Support routine and non-routine service provider visits, internal and cross-functional investigations, and software / firmware upgrades and assessments.
• Respond to the Engineering Operations support ticketing system in a timely manner, escalating where appropriate.
• Respond to environmental monitoring system alert notifications for cold storage units and laboratory temperature/humidity sensors in a timely manner, escalating where appropriate.
• Provide technical training and transfer knowledge to fellow engineers/technicians and clinical laboratory operators.
• Participate and adhere to GRAIL’s policies and guidelines.
• Recommend and implement changes to ensure ongoing high-quality performance of laboratory equipment as part of the continuous improvement process.
• Support identification of and solutions to the root cause of software and hardware discrepancies, deviations and non-conformances.

Preferred Qualifications;

• 1+ years experience using Blue Mountain RAM or similar asset management software
• 1+ years experience using Laboratory Information Management Systems (LIMS)
• 1+ years experience maintaining low volume automated liquid handling systems (e.g. MultiFlo/Bravo, STAR/STARlet, Echo, Lynx, Lunatic, high throughput NGS sequencers)
• 1+ years experience writing and implementing test protocols and procedures
• 1+ years experience using Green Button Go
• Basic knowledge of molecular biology, biochemistry to support equipment usage and maintenance in a high throughput testing environment

Required Skills;

• 1+ years technical documentation experience within a regulated environment
• 1+ years experience completing work in accordance with stated deadlines
• 1+ years experience contributing to cross-functional team initiatives
• 1+ years technical troubleshooting and root cause analysis experience
• 1+ years experience utilizing networked laboratory systems and basic laboratory equipment (pipettes, thermal cyclers, centrifuges, plate washers, etc.)

Education Requirements;

• Bachelor’s degree or equivalent in Engineering, Physics, Chemistry, or similar Life Sciences discipline

Physical Demands & Working Environment;

• Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, and wear safety gear.
• Occasionally work with dry ice or materials stored at very low temperatures.
• Must be able to stand or sit for long periods of time.
• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.
• Must regularly lift and / or move up to 10 pounds.
• Must frequently lift and/or move up to 25 pounds.
• Must occasionally lift and/or move up to 50 pounds.
• Travel may be required, up to 10% of the time.