GRAIL is seeking a Equipment Equipment II for the Engineering Operations team for all possible shifts. As an Equipment Engineer II, you will provide site-wide support for clinical and non-clinical operations activities while implementing global solutions. Responsibilities will include 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 is a full time, onsite position working in the Research Triangle Park, NC lab.

1st Shift Start Time: 8:00am EST

2nd Shift Start Time: 4:00pm EST

3rd Shift Start Time: 12:00am EST

Work on holidays may be required

Working hours may be temporarily adjusted due to business demands, training, travel, and other events.

Responsibilities;

• Perform troubleshooting, recovery, debugging, and repairs on laboratory systems and equipment. 
• Execute Equipment Lifecycle Management processes and procedures by supporting and maintaining equipment records for traceability purposes in compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 / 15189 requirements, and the GRAIL QMS (Quality Management System)
• 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
• Defines, supports, develops, administers, and refines the Asset Management preventive/predictive maintenance programs
• Reduce and improve unplanned maintenance wherever feasible, assuring efficient and productive operation of equipment. Prolong the economic life of assets at the lowest practical cost.
• Supports engineered solutions to mitigate repetitive failures that adversely affect plant availability, performance, capacity, quality, cost, or regulatory compliance
• Create and update: procedures, work instructions, guidelines, and testing documents such as installation / operational / verifications, standard operating procedures (SOP)
• Manage and source vendors to support qualifications, installations, calibrations, investigations, upgrades, preventive maintenance (PM), and/or repairs as needed
• Provide technical training, support in the creation of new training, and transfer knowledge to fellow engineers and laboratory operators
• Support the investigations and act as a subject matter expert in NCRs, CAPAs, and associated quality and technical investigations

Preferred Qualifications;

• 2+ years experience using an asset computerized maintenance management system (CMMS)
• 2+ years experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems (MES), Customer Relationship Management (CRM) software
• 1+ years experience project management 
• 1 + years experience with data analysis techniques including statistical process control, OEE, reliability modeling and prediction, RCA techniques, and/or sig sigma methodology 

Required Skills;

• 2+ years of related experience with a BS/BA or higher degree in Engineering of equivalent work experience.
• 2+ years experience of demonstrated knowledge in problem solving and in particular the RCA process
• 2+ years experience of technical writing within a regulated environment 
• 2+ years experience maintaining low volume automated liquid handling systems (e.g. MultiFlo/Bravo, STAR/STARlet, Echo, Lynx, Lunatic, high throughput NGS sequencers)
• Basic knowledge of molecular biology, biochemistry to support equipment usage and maintenance in a high throughput testing environment

Required Education;

• Bachelor’s degree or equivalent in Engineering, Physics, Chemistry, or similar Life Sciences discipline. Engineering degree preferred

Physical Demands & Working Environment;

• Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, and wear safety gear.
• Hours and days may vary depending on operational needs.
• Working with dry ice may be necessary.
• Standing or sitting for long periods of time may be necessary.
• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.
• Must occasionally lift and / or move up to 10 pounds.
• Must occasionally lift and/or move up to 25 pounds.
• Must occasionally lift and/or move up to 50 pounds.
• Travel may be required, up to 10% of the time.