Supervisor, Engineering Operations (Wed-Sat - 6AM to 4PM) - #4500 at GRAIL
GRAIL · Durham, United States Of America · On-site
- Office in Durham
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
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, heating or freezing elements, and high-speed centrifugation