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Salary: USD 90,725 - 116,025 / annual
Freenome is seeking an Automation Service Engineer II to join the Automation Service team and support laboratory equipment lifecycle management for their cancer diagnostic testing platform. This role is responsible for ensuring Laboratory Equipment Lifecycle Management processes (onboarding, IQ, OQ, PQ, calibration, maintenance, pFMEA, decommission) adhere to regulatory requirements on large, fully automated laboratory systems.
Key Responsibilities:
- Support and perform equipment installations, qualifications, scheduled and unscheduled maintenance activities to ensure instrument reliability and uptime
- Coordinate and schedule unscheduled maintenance activities between internal and external customers
- Perform routine and preventative maintenance activities, including post-PM procedures (instrument teaching, move tests, qualification work, documentation) while ensuring maximum uptime and QMS compliance
- Participate in on-call rotations, responding to P0-P1 issues on critical and non-critical equipment in the clinical laboratory
- Support equipment lifecycle through troubleshooting, calibration support, training, and asset inventory management
- Communicate equipment status, maintenance activities, and updates with internal customers
- Contribute to administration and maintenance of the computerized maintenance management system (CMMS)
- Ensure laboratory documentation is accurate, complete, and GMP-compliant
- Coordinate with third-party service providers and vendors
- Support, configure, and maintain temperature monitoring systems for cold storage and environmental monitoring
- Manage 5S spare parts inventory to support laboratory operations and scalability
- Provide equipment service and operational support during normal business hours and after hours, including weekends as required
Reporting to the Supervisor of Equipment, Service and Maintenance Engineering Operations (with initial reporting to the Manager, Automation Service Engineering).
Requirements:
- B.S. degree in engineering or scientific discipline with minimum 2 years related experience; or advanced degree without experience; or equivalent work experience
- Experience and knowledge providing laboratory equipment support for Clinical and R&D environments for Hamilton and Bravo Liquid Handlers, Illumina Sequencers, and various ancillary laboratory instrumentation
- Ability to effectively communicate and collaborate with internal and external colleagues from diverse scientific, engineering, operational, and regulatory disciplines
- Excellent communication skills to work with high-dynamic cross-functional teams
- Strong team player with communication, collaboration, active listening, and problem-solving skills
- Schedule flexibility required; position initially Monday-Friday 9am-5pm, then shifts to one of: Monday-Friday 7:30am-3:30pm, Monday-Friday 10:30am-6:30pm, or Tuesday-Saturday 9am-5pm (4 weeks notice for changes)
Nice to Have:
- Proficiency in service support for Hamilton and Bravo robotic liquid handlers
- Experience with various laboratory instrumentation
- Familiarity with developing and executing training programs
- Experience authoring laboratory equipment PM, IQ, OQ, PQ, repair, and service documentation
- Experience in CLIA, CAP, PMA, GDP, GMP regulated environments
- Experience standardizing processes for scalability and sustainability
- Hands-on technical troubleshooting skills in high-throughput sample processing laboratories
- Experience with 5S, Lean Manufacturing, Six Sigma methodologies
- Liquid handler programming experience