Operations Engineer 2 (2nd Shift - Wednesday - ...

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=

Created: 2026-02-20