Supervisor, Engineering Operations (Sun-Wed - 6AM to 4PM) - #4529

Responsibilities

• ​Supervise, coach, and support a small team of engineers and technicians performing live troubleshooting, recovery, debugging, repairs, and preventive maintenance of complex automation hardware and robotics, laboratory equipment and systems
• Provide day-to-day technical leadership to support clinical laboratory operations in compliance with cGMP/GLP and Quality Management System (QMS/eQMS) requirements
• Serve as a hands-on technical lead with working knowledge of laboratory automation hardware, software, and process fundamentals
• Execute equipment lifecycle management activities, supporting installations, maintenance, calibration, qualification, repair, and decommissioning, ensuring complete and accurate documentation
• Maintain equipment records and traceability within asset management systems in compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 requirements
• Lead root cause investigations and failure analysis; drive corrective and preventive actions (CAPAs) for both hardware and software issues
• Make time-sensitive technical decisions to restore operations and minimize downtime
• Drive continuous improvement initiatives to reduce unplanned maintenance and improve equipment reliability and maintainability
• Partner closely with Quality and Regulatory teams to ensure equipment lifecycle events meet applicable policies, procedures, and regulatory requirements
• Manage and coordinate external vendors supporting qualifications, calibrations, installations, upgrades, preventive maintenance, investigations, and repairs
• Respond to and resolve equipment-related issues and environmental monitoring system alerts in a timely manner
• Lead and execute failure reporting, analysis, and corrective action systems
• Develop and deliver technical training; support creation of new training materials and transfer knowledge to engineers, technicians, and laboratory operators
• Prepare reports, metrics, and tracking tools to monitor performance, reliability, and operational effectiveness
• Demonstrate flexibility in work schedule and adjust priorities to meet operational needs
• Act as a role model by adhering to GRAIL policies, safety standards, and quality guidelines
These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

Required Qualifications

• Bachelor’s degree in Engineering or related field (or equivalent experience)
• 5+ years of experience in an engineering, maintenance, or operations support role
• 3+ years of hands-on experience maintaining and supporting laboratory equipment involving both hardware and software components
• 2+ years of experience troubleshooting and maintaining liquid handling and laboratory automation equipment (e.g., Agilent, Hamilton, Labcyte, Illumina, or similar platforms)
• 3+ years of experience writing and executing test protocols, procedures, or validation documentation
• 1+ years of experience working in a regulated clinical laboratory environment
• 1+ years of experience supporting IT networking and systems infrastructure
• 1+ years of experience working within a computerized maintenance or calibration management system (CMMS)
• Strong communication and leadership skills to support teams and internal stakeholders
• Strong time management skills and ability to operate effectively in a fast-paced environment
• Ability to travel up to 10%

Preferred Qualifications

• Prior supervisory or team-lead experience in engineering or laboratory operations
• Experience supporting high-throughput or 24/7 clinical laboratory environments
• Familiarity with ISO 13485, CLIA/CAP, FDA QSR, and equipment validation practices
• Experience partnering with Quality and Regulatory teams on NCRs, CAPAs, and audits

Physical Demands & Working Environment

• Hours and days may vary depending on operational needs
• Regularly required to stand, sit, walk, climb stairs or ladders, kneel, crouch, and wear appropriate safety gear
• Regularly lift and/or move up to 10 pounds; frequently lift and/or move up to 25 pounds; occasionally lift and/or move up to 50 pounds
• Working with dry ice may be necessary
• Working in confined spaces may be required
• May be exposed to hazardous materials, blood specimens, and instruments with moving parts, heatin​g or freezing elements, and high-speed centrifugation