Equipment Engineer 2 #3304 (First Shift)

You Will;

• 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;

• Required:
• 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
• Preferred:
• 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.