Staff Design Quality Engineer

Scope: 

The Genomics Automation Specialist serves as the technical owner for assigned laboratory automation systems at the Livingston site. This position is responsible for ensuring reliable, compliant, and efficient operation of automated laboratory platforms through preventive maintenance, troubleshooting, validation support, lifecycle management, and continuous improvement. The role partners closely with Automation Engineering while progressively assuming ownership of assigned systems, serving as the site automation subject matter expert, and supporting standardization of automation practices across Cooper Genomics.

Job Summary:

The Genomics Automation Specialist is responsible for the operation, maintenance, qualification, continuous improvement, and lifecycle management of assigned laboratory automation platforms. The role serves as the primary automation resource for designated systems and partners with laboratory operations, quality, engineering, IT, and external vendors to ensure validated, compliant, and reliable laboratory automation.

Works collaboratively with Automation Engineering to support automation strategy while independently managing assigned laboratory automation systems.

Acts as the designated technical owner and subject matter expert for assigned laboratory automation platforms throughout their operational lifecycle.

Essential Functions & Accountabilities:

1. Perform routine inspections, preventive maintenance, calibration, and operational checks on laboratory automation systems and supporting instrumentation.
2. Troubleshoot automation hardware, software, and process-related issues to rapidly restore system functionality and minimize operational downtime.
3. Execute equipment setup, installation, qualification, and validation activities in support of new automation platforms, process improvements, and system upgrades.
4. Assist with investigation, root cause analysis, corrective actions, and resolution of automation-related deviations, equipment failures, and performance issues.
5. Support automated liquid handling systems, thermal control devices, robotic transport systems, and associated laboratory instrumentation.
6. Perform basic automation software configuration, method execution support, system backups, and approved programming modifications under engineering guidance.
7. Maintain equipment documentation, maintenance records, calibration records, validation documentation, and change control records in accordance with quality system requirements.
8. Coordinate with laboratory operations, quality assurance, engineering, and external vendors to support equipment maintenance, repairs, upgrades, and continuous improvement initiatives.
9. Assist in the development, revision, and execution of SOPs, work instructions, preventive maintenance procedures, and training materials related to laboratory automation systems.
10. Monitor automation system performance and identify opportunities to improve reliability, throughput, compliance, and operational efficiency.
11. Support spare parts inventory management, consumable tracking, and equipment lifecycle activities to ensure continued system availability.
12. Adhere to all applicable safety, quality, regulatory, and data integrity requirements while working within a regulated laboratory environment.
13. Remain current on advancements in laboratory automation technologies and participate in ongoing technical training and professional development activities.
14. Provide day-to-day operational support for automated laboratory systems and serve as a primary resource for first-line automation troubleshooting and maintenance activities.
15. Serve as the primary system owner for assigned laboratory automation platforms, ensuring equipment remains qualified, compliant, operational, and aligned with laboratory requirements.
16. Lead technical investigations for automation-related deviations, recommend corrective actions, and coordinate implementation across cross-functional teams.
17. Identify, develop, and implement continuous improvement initiatives that improve automation reliability, throughput, compliance, and user experience.
18. Provide technical mentorship and knowledge transfer to laboratory personnel, new automation specialists, and cross-functional teams supporting automated laboratory systems.
19. Participate in evaluation, implementation, and commissioning of new automation platforms while supporting standardization of automation practices across multiple laboratory sites.

 

 

 

Knowledge, Skills, and Abilities:

• Strong troubleshooting and problem-solving skills with the ability to diagnose mechanical, electrical, software, and process-related issues.
• Working knowledge of automated laboratory systems, robotics, liquid handling platforms, instrumentation, or related automated equipment.
• Understanding of mechanical systems, motors, sensors, pneumatics, and basic electrical principles.
  Ability to perform preventive maintenance, equipment setup, calibration, and operational support activities.
• Ability to read and interpret technical documentation, equipment manuals, SOPs, work instructions, and engineering drawings.
• Strong organizational skills and attention to detail in a regulated environment.
  Ability to accurately document maintenance activities, investigations, equipment performance, and corrective actions.
• Effective verbal and written communication skills with the ability to collaborate across laboratory operations, quality, engineering, and vendor teams.
• Experience modifying automation methods, troubleshooting automation software, and supporting validated laboratory automation workflows.
• Knowledge of validation, change control, deviation management, and quality system requirements preferred.
  Commitment to safety, quality, compliance, and continuous improvement.
• Demonstrated ability to independently manage complex laboratory automation systems while serving as a technical resource for laboratory operations and engineering.

Work Environment:

• Occasional lifting of up to 35 kilograms may be required.

• Ability to work in uncomfortable positions, when required. For example, when repairing various manufacturing equipment.

 

Experience:

• Minimum 4 years of experience supporting laboratory automation systems, laboratory instrumentation, manufacturing automation systems, or related technical equipment.
• Experience working in a regulated environment (CLIA, CAP, FDA, GxP, Medical Device, Pharmaceutical, Biotechnology, or Life Sciences) preferred.
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Education:

• Associate’s degree in Engineering Technology, Automation, Electronics, Biotechnology, Molecular Biology, Life Sciences, or a related technical discipline required.
• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Automation, or related field preferred.
• Equivalent combinations of education, military training, technical certifications, and directly related experience will be considered.