Equipment Engineer 2 #3304 (First Shift)
Durham, NC, USA
Posted on Wednesday, October 25, 2023
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.
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.
- 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
- Maintain Asset Management System to support internal Equipment Program processes and procedures
- 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 improves unplanned maintenance wherever feasible, assuring efficient and productive operation of equipment. Prolong the economic life of assets at the lowest practical cost
- Collaborate in addressing cost saving initiatives and/or strategic long-term issues affecting the organization
- Supports engineered solutions to mitigate repetitive failures that adversely affect plant availability, performance, capacity, quality, cost, or regulatory compliance
- Respond and solve equipment related issues in a timely manner
- Support failure reporting; analysis and corrective actions systems
- Create and update: procedures, work instructions, guidelines, and testing documents such as installation / operational / verifications, standard operating procedures (SOP)
- Support root cause investigations that drive for resolutions to completion.
- 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
- Support the 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
Your Background Should Include;
- 2+ years of related experience with a BS/BA or higher degree in Engineering or equivalent work experience
- Demonstrated knowledge in problem solving and in particular the RCA process
- Excellent communication skills and provide internal customer support
- Excellent time management skills to support a fast-paced working environment
- Strong industrial, electrical, and mechanical knowledge
- Knowledge of systems infrastructure
- Understanding of Asset Management Lifecycle
- Experience working in a clinical laboratory regulated environment
- Proven experience planning within a computerized maintenance/calibration management (CMMS) system and working with computer programs (Google, Office, Excel, Project, etc…)
- Knowledge Safety Training, lock out tag out (LOTO), Hazardous material, and waste handling
- Experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems (MES), scheduling software, Customer Relationship Management (CRM) software
- Experience planning in Blue Mountain RAM
- Calibration experience
- Project management skills
- Competency with data analysis techniques including statistical process control, OEE, reliability modeling and prediction, RCA techniques, and/or sig sigma methodology
- Competency in implementation of predictive technologies
Physical Demands / Working Environment;
- Travel up to 20% 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.
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.