Operations Engineer 2 #3274 (First Shift)

You Will;

• Work on GRAIL’s groundbreaking, fully automated, high throughput laboratory systems in order to keep high uptime on a variety of processes that help our next generation sequencing (NGS) cancer diagnostics workflows.
• Work with vendors to support Installation / Operational Qualifications (IOQs), calibrations, investigations, upgrades, preventative maintenance (PMs), and/or repairs as needed.
• Perform live troubleshooting, recovery, debugging, repairs, and maintain equipment and systems in good working order to support the area and operator’s day to day following cGMP/GLP and Quality Management System (QMS) guidelines.
• Execute and document all equipment lifecycle related activities (installations, maintenance, calibration, internal qualifications, repairs, etc.) by supporting and maintaining equipment records in our Asset Management System for traceability purposes and to assure compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 / 15189 requirements.
• Respond to environmental monitoring system alert notifications for cold storages and laboratory temperature/humidity sensors.
• Revise, update, and execute, test plans, IOPQ, site acceptance testing (SAT), verifications, and standard operating procedures (SOPs) as needed.
• Provide technical training and transfer knowledge to fellow engineers/technicians and 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.

Your Background Should Include:

• Required:
• Good communication skills to work independently and provide internal customer support.
• Excellent time management skills to support a fast paced working environment.
• Good troubleshooting and root cause analysis skills.
• Basic knowledge of IT networking and systems infrastructure.
• Basic knowledge of laboratory equipment and systems.


• Preferred:
• Experience in technical troubleshooting skills in both hardware and software components.
• Experience with writing and implementing test protocols and procedures.
• Experience working in a high throughput clinically regulated environment working with automated equipment/systems.
• Basic knowledge of molecular biology to best support equipment activities.
• Experience maintaining Illumina NGS technology platforms.
• Experience executing within a computerized maintenance/calibration management system and Customer Relationship Management (CRM) software (Blue Mountain).
• Experience maintaining automated liquid handling platforms (e.g., Agilent, Hamilton, Beckman Coulter Echo, Dynamic Devices, Illumina Sequencers).
• Experience working with Green Button Go (GBG).
• Experience working under cGxP (Documentation, Manufacturing, Automation Manufacturing, Laboratory)

Engineer 1 vs 2 Requirements;

• Engineer 2 Requirements:
• 2 - 5+ years of related experience with a Bachelor’s degree or equivalent work experience.
• BS/BA or equivalent in Engineering, Physics, Chemistry or Life Sciences.


• Engineer 1 Requirements:
• 0 - 2 years of related experience with a Bachelor’s degree or equivalent work experience.
• BS/BA or equivalent in Engineering, Physics, Chemistry or Life Sciences.

Physical Demands/Working Environment:

• Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear.
• Must regularly lift and / or move up to 10 pounds.
• Frequently lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Travel up to 10%