Operations Engineer 2 (2nd Shift - Wednesday - ...
GRAIL, Inc - Durham, NC
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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. Required Qualifications - - Bachelors 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. Preferred Qualifications - - 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. Physical Demands and Working Environment - - Hours and days may vary depending on operational needs. - Standing or sitting for long periods of time may be necessary. - May be exposed to hazardous materials, blood specimens, and instruments with moving parts, heating or freezing elements, and high-speed centrifugation. - Regularly required to stand, walk, climb stairs or ladders, kneel, crouch, and wear appropriate safety gear. - Some lifting (up to 25 pounds) may be necessary. - Ability to travel up to 10% as required. ::: {qa=closing-description} Expected full time annual base pay scale for this position is $82K-$101K. Actual base pay will consider skills, experience and location This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidates qualifications. Employees in this role are also eligible for GRAILs 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. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, , or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at you require an accommodation to apply for an open position. :::
Created: 2026-02-20