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Hybrid Associate Engineer - Physical Monitoring en Abeona

Abeona · Cleveland, Estados Unidos De América · Hybrid

Microsoft Excel

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Position Overview
We are seeking a dedicated and detail-oriented Associate Engineer to join our team. The successful candidate will be responsible for the physical monitoring of our cGMP facility, ensuring that all incubators, refrigerators, freezers, and cryogenic units are maintained in a state of control as well as the environment of the clean rooms.  This role involves issuing Quality Events, assessing the impact of alarms, troubleshooting units, and coordinating with approved vendors for routine Preventative Maintenance and Calibrations.
 
Essential Duties and Responsibilities
  • Perform physical monitoring of incubators, refrigerators, freezers, and cryogenic units within clean space and quality control laboratories and monitor differential pressures, temperature, and humidity of clean rooms (ISO Class 7 and 8) to ensure they are maintained in a state of control.
  • Collect, analyze, and interpret data from monitoring systems to identify trends and potential issues.
  • Identify, troubleshoot, and resolve issues with units promptly to minimize downtime.
  • Work closely with other departments, including Quality Assurance and Manufacturing, to ensure a cohesive approach to compliance and monitoring.
  • Issue Quality Events and collaborate with the owning department to assess the impact when alarms occur.
  • Coordinate with approved vendors to schedule and perform routine Preventative Maintenance and Calibrations.
  • Maintain accurate records of all monitoring activities, maintenance, and calibration performed.
  • Prepare and present reports on monitoring activities and findings to management.
  • Ensure compliance with cGMP regulations and company policies.
  • Participate in continuous improvement initiatives to enhance facility operations.
Qualifications
  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • Experience in a cGMP facility or similar regulated environment is preferred.
  • Strong troubleshooting and problem-solving skills.
  • Excellent communication and collaboration abilities.
  • Detail-oriented with a commitment to maintaining high standards of quality and compliance.
  • Proficiency in data analysis and reporting.
  • Ability to work independently and as part of a team.
  • Flexibility to handle changing priorities and work in a dynamic environment.
Physical Demands
  • Must be able to perform physical tasks such as lifting and moving inventory.
  • Must be comfortable standing and walking for extended periods.
  • Comfortable working in environments with varying temperatures.
  • May be required to bend, stoop, and stretch for a prolonged period.
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