Operations Engineer 2, MSAT # 4411

Grail • Durham, NC

48d • Onsite

About The Position

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. GRAIL is seeking an Operations Engineer 2 for the Manufacturing Sciences and Technology team. As an Operations Engineer 2, you will provide support for Manufacturing and Lab Operations activities. Responsibilities will include the installation, maintenance, and sustained performance of cutting-edge laboratory equipment along with documenting activities in accordance with regulatory compliance guidelines. Laboratory equipment supported will range widely, but will include next-generation sequencing platforms and automated liquid handling robots. Strong interpersonal, organizational, and troubleshooting skills are essential for success in this position. This is a full time, onsite position working in the Research Triangle Park, NC lab. This is a first shift position, Monday to Friday starting at 8:00AM. Work on holidays may be required. On-call work may be required. Working hours may be temporarily adjusted due to training, travel, and other events.

Requirements

• BS/BA or equivalent in Engineering, Physics, Chemistry or Life Sciences with 2+ years of experience working on laboratory equipment or in an equivalent program
• AS or applicable certification with 5+ years of experience working on laboratory equipment or equivalent program
• Excellent communication skills to serve as a point of contact for internal customer support
• Excellent time management skills to support a fast paced working environment
• Ability to travel up to 10% of the time

Nice To Haves

• 1+ years Hands-on experience maintaining and supporting general molecular laboratory equipment (hardware and software systems) and following appropriate safety procedures
• 1+ years experience technically troubleshooting and maintaining liquid handling equipment and software components (e.g., Agilent, Hamilton, Labcyte, Illumina etc.)
• 1+ years experience working in a regulated laboratory environment
• 1+ years experience working with IT networking and systems infrastructure
• 1+ years experience working within a computerized maintenance/calibration management system

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 in a timely manner
• Make time sensitive technical decisions; collaborate and escalate when appropriate
• Ensure day-to-day 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 events wherever feasible, ensuring efficient and productive operation of equipment
• Execute and document equipment lifecycle related activities (installations, maintenance, calibration, 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
• Maintain Asset Management System(s) to support internal Equipment Program processes and procedures
• Execute procedures, work instructions, guidelines, and testing documents such as installation / operational / performance qualification (IOPQ), site acceptance test (SAT), verifications, standard operating procedures (SOP)
• Serve as a primary point of contact for hosting vendor IQ, OQ, calibration, PM, and/or repairs with minimal supervision
• Ensure that all work performed by external contractors is completed and documented in accordance with the site Quality Management System (QMS) and safety guidelines
• Work closely with quality and regulatory to determine, include, implement and follow the required policies, requirements, and procedures for equipment lifecycle events
• Author and lead DAR implementations where needed; may lead equipment and equipment integration- related Change Controls for qualified assets
• Respond to environmental monitoring system alert notifications for areas of responsibility

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Ambulatory Health Care Services
• Number of Employees: 501-1,000 employees