Operations Engineer I/II (RTP) #2708
Raleigh-Durham, NC /
Research & Development – Lab Operations /
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
***WE STRONGLY ENCOURAGE NEW GRADS TO APPLY***
The Operations Engineer I/II will support, coordinate, and provide technical engineering support for a variety of processes, automation hardware, software applications, and laboratory equipment/systems. The Operations Engineer will primarily interact with clinical operations, research scientists, and software developers to ensure smooth running of a complex operation system. 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 team member to help deliver our revolutionary test to as many people as possible. There are multiple positions for this job. This position will be for a 4x10 shift with potential for minor changes in hours as the team expands, there are 4 shifts available (6am-4pm or 2pm-12am; Wed-Sat or Sun-Wed). Holiday support may be required.
- 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 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 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
- 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.
- 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 II 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 I 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%
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.