Operations Engineer 2 (2nd Shift - Wednesday - Saturday 2 pm to 12 am) - #4501

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 role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

Required Qualifications

• Bachelor’s 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 & 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.