Senior Operations Engineer (Lab Equipment Qualifications) #2557

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 OUR VETERAN COMMUNITY TO APPLY***

The Senior Operations Engineer will coordinate, manage tasks, mentor talent, and provide technical engineering support for a variety of process automation hardware, software applications, and laboratory equipment. They will primarily interact with clinical operations, research scientists, and software developers to ensure smooth running of our very complex operation system. This includes both supporting day to day debugging and problem solving of inevitable issues that arise, and working to continuously improve our systems, but helping gather requirements and prioritize improvements.  GRAIL’s testing volumes are scaling fast and require a dynamic and detail oriented lead to help deliver our revolutionary test to as many people as possible.  
This position requires on-call duty and may need to support weekends and holidays.
You Will:

• Lead area work responsibilities, effectively triage opportunities, direct work based on team skill set, and coach and guide junior level staff.
• Lead and perform live troubleshooting, recovery, debugging, repairs, and maintain equipment and systems in good working order to support the area and operators’ day to day following cGMP/GLP and Quality Management System (QMS) guidelines.
• Lead root cause investigations, drive for resolutions, and follow 
• those up with corrective and preventative actions for software and hardware opportunities. Be the technical lead by knowing software, processes, and hardware fundamentals.
• Make time sensitive technical decisions.
• Manage spare parts inventory for area of responsibility.
• Manage, source, and coordinate vendors to support qualifications, installations, calibrations, investigations, upgrades, preventive maintenance (PM), and/or repairs as needed.
• Create, update, and execute procedures, work instructions, guidelines, and testing documents such as installation / operational / performance qualification (IOPQ), site acceptance test (SAT), verifications, standard operating procedures (SOP).
• Execute and document all equipment lifecycle related activities (installations, maintenance, calibration, qualifications, repairs, etc) by supporting and maintaining equipment records in and out of our Asset Management System for traceability purposes and to assure compliance with CLIA/CAP, FDA 21 CFR part 820, and ISO 13485 requirements.
• Provide technical training, support in the creation of new training, and transfer knowledge to fellow engineers and laboratory operators.
• Respond to environmental monitoring system alert notifications for cold storages and laboratory temperature/humidity sensors for area of responsibility.
• Participate, be a role model, 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 the improvement of GRAIL’s groundbreaking, fully automated, high throughput laboratory equipment and systems and provide expertise with solving all things automation and liquid handling (Hamilton, Agilent, Bravos, Beckman Echo, Illumina) in order to optimize multiple processes associated with our NGS cancer diagnostics workflows.
• Support the investigations and act as a subject matter expert in NCRs, CAPAs, and associated quality and technical investigations.

Your Background Should Include:

• REQUIRED:
• 5 - 8+ years of related experience with a BS/BA or higher degree in Engineering, Physics, Chemistry or Life Sciences or equivalent work experience.
• Demonstrated ability to successfully lead, coach, and mentor junior level engineers.
• Excellent communication skills to work as a leader and provide internal customer support.
• Excellent time management skills to support a fast paced working environment.
• Excellent troubleshooting and root cause analysis skills in both hardware and software.
• Strong experience with writing and implementing test protocols and procedures.
• Strong industrial electrical and mechanical knowledge.
• Knowledge of IT networking and systems infrastructure.
• Experience working in a clinical laboratory regulated environment.
• Experience executing within a computerized maintenance/calibration management system.
• Knowledge Safety Training, lock out tag out (LOTO), Hazardous material, and waste handling.
• PREFERRED:
• Strong experience in technical troubleshooting and maintenance in both hardware and software components in regards to liquid handling equipment.(e.g., Agilent, Hamilton, Tecan, Labcyte, Illumina etc.)
• Hands-on experience supporting equipment in a high throughput clinical laboratory operation.
• Experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems(MES), scheduling software, Customer Relationship Management (CRM) software.
• Knowledge of molecular biology to best support equipment activities in an next generation sequencing (NGS) workflow.
• Project management skills.
• Experience working with Green Button Go (GBG).
• Experience working with Illumina NGS technology platforms.

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% of the time

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.

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.

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.