Operations Engineer 2 (2nd Shift - Wednesday - Saturday 2 pm to 12 am) - #4501
About The Position
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicineâs greatest challenges. GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com GRAIL is seeking an Operations Engineer II who is a hands-on technical leader responsible for supporting complex laboratory automation systems, robotics, and associated instrumentation within Grailâs clinical laboratory operations. This role performs live troubleshooting, debugging, repair, preventive maintenance, and lifecycle management of laboratory equipment while ensuring compliance with cGMP/GLP, CLIA/CAP, FDA 21 CFR Part 820, ISO 13485, and internal Quality Management System (QMS/eQMS) requirements. The ideal candidate combines strong technical expertise in automation hardware and software with sound engineering judgment, regulatory awareness, and the ability to make timely decisions in a high-throughput clinical environment. This role is based in Durham NC at our lab working 4 days a week - Wednesday - Saturday from 2pm to 12am.
Requirements
- Bachelorâs degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Systems Engineering, or related field or equivalent work experience.
- 3+ years of experience supporting complex automation systems in a regulated environment (clinical laboratory, medical device, biotechnology, or pharmaceutical).
- Experience troubleshooting electromechanical systems, robotics, sensors, motion control, and integrated automation platforms.
- Working knowledge of regulatory requirements including CLIA/CAP, FDA 21 CFR Part 820, ISO 13485, and cGMP/GLP.
- Experience leading root cause investigations and implementing CAPAs.
- Experience documenting work within QMS/eQMS and asset management systems.
- Ability to operate effectively in a fast-paced, high-throughput clinical environment.
Nice To Haves
- Experience supporting high-complexity clinical laboratory automation platforms.
- Familiarity with PLCs, industrial controls, robotics programming, or automation software platforms.
- Experience executing validation and equipment qualification protocols (IQ/OQ/PQ).
- Lean, Six Sigma, or reliability engineering experience.
- Prior experience mentoring junior staff or leading small technical initiatives.
- Experience analyzing downtime metrics and implementing reliability improvement strategies.
Responsibilities
- Perform live troubleshooting, recovery, debugging, repair, and preventive maintenance on complex laboratory automation systems, robotics, and associated hardware and software.
- Serve as a primary escalation point for technical issues impacting laboratory throughput, quality, and service levels.
- Make time-sensitive engineering decisions to restore operations and minimize downtime in a high-throughput clinical environment.
- Analyze system performance data to proactively identify risks, prevent failures, and improve reliability.
- Lead root cause investigations and failure analyses for hardware and software issues; drive corrective and preventive actions (CAPAs) and ensure effectiveness checks.
- Partner with Quality and Regulatory teams to ensure equipment lifecycle activities align with cGMP/GLP, CLIA/CAP, FDA 21 CFR Part 820, ISO 13485, and internal QMS/eQMS requirements.
- Support internal and external audits as a subject matter expert for laboratory automation systems.
- Develop and execute continuous improvement initiatives to reduce unplanned maintenance, enhance maintainability, and improve equipment reliability.
- Mentor junior engineers and technicians, guiding troubleshooting strategies and technical best practices.
- Collaborate cross-functionally with Laboratory Operations, Quality, Regulatory, IT, and external vendors to support compliant and efficient clinical operations.
- These responsibilities summarize the roleâs primary responsibilities and are not an exhaustive list. They may change at the companyâs discretion.
Benefits
- Employees in this role are also eligible for GRAILâs comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
