Senior Operations Engineer - 4024

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com.
The Senior Operations Engineer will be responsible for all the aspects of GRAIL's asset lifecycle program including installation, maintenance, and performance of cutting-edge laboratory equipment and may include preventive, predictive, correct, projects, qualification, etc. along with documenting activities in accordance with regulatory compliance guidelines. Supporting laboratory equipment will range widely but will include next-generation sequencing platforms and automated liquid handling robots. This position will be working in close collaboration with the clinical and non-clinical lab staff and multi-functional teams. Strong interpersonal and troubleshooting skills are essential for success in this position.  This onsite role requires 5 days a week in Durham, NC (RTP Site)This is a full time position working in our lab starting at 8:00AM Monday through FridayThe working hours could be temporarily adjusted due to training, travel, and other events.This position requires on-call duty and may need to support weekends and holidays.

Responsibilities:

• 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
• Execute Equipment Lifecycle Management processes and procedures by supporting and maintaining equipment records for traceability purposes in compliance with CLIA/CAP and ISO 13485 requirements
• 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
• Guides efforts to ensure reliability and maintainability of equipment, processes, mechanical, electrical, control, and safety/security systems following cGMP/GLP and Quality Management System (eQMS) guidelines
• Reduce and improve unplanned maintenance wherever feasible, assuring efficient and productive operation of equipment
• 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 area of responsibility.
• Respond and solve equipment related issues in a timely manner
• Lead and executes failure reporting; analysis and corrective actions systems
• Demonstrate flexibility in work schedule and can adjust priorities as needed
• Manage and source vendors to support qualifications, installations, calibrations, investigations, upgrades, preventive maintenance (PM), and/or repairs as needed
• Participate, be a role model, and adhere to GRAIL’s policies and guidelines
• Preparation of reports, metrics, and other tracking tools measuring / allowing for success
• Provide technical training, support in the creation of new training, and transfer knowledge to fellow engineers and laboratory operators
• Lead investigations and act as a subject matter expert in NCRs, CAPAs, and associated quality and technical investigations
• Work closely with quality and regulatory to determine, include, implement and follow the required policies, requirements, and procedures for equipment lifecycle events

Preferred Qualifications:

• 5+ years of related experience with a BS/BA or higher degree in Engineering or equi