Operations Engineer 1 (3rd shift) #3512

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.