Goodwin Biotechnology

Scope of Function:  The Senior Facilities and Utilities Engineer is responsible for providing engineering support for the Facilities and Utility systems such as: Pest Control, Plant steam boiler, HVAC, Purified Water System, Process chillers, Air Compressors, Sterilizers, Bioreactors, Freezers, Refrigerators and Incubators, including preventative maintenance and equipment qualification support. The Senior U&F Engineer leads a group of hourly technicians that are both experienced and diversified. The candidate will be responsible for generating and maintaining all the documentation of the executed preventive and corrective maintenance and prepare summary reports as required for the monthly PM schedule. The candidate shall fully comply with all regulatory / cGMP guidelines, standards, and policies.

Reports to:  Associate Director of Facilities and Engineering

 

Specific Duties: 

  • Performs equipment and utilities troubleshooting and assists with the repair of various equipment and systems
  • Supports and writes investigations and assist in development and implementation of CAPAs
  • Assists in the execution of the scheduled preventative maintenance and documentation of Work Orders
  • Oversees and directs maintenance personnel with repairs
  • Hold direct report team accountable for performance
  • Conduct annual performance review of direct reports
  • Support and develops responses for internal and external audits
  • Develop Standard Operating Procedures (SOPs) and Change Controls pertaining to setup, maintenance, and operation of equipment, facility, and utilities
  • Support the purchase and implementation of new equipment and spare parts
  • Identify the equipment, systems and processes that do not operate efficiently; develop and implement corrective actions to improve efficiency
  • Ensure that required parts are available for the projects, preventative maintenance and repairs
  • Coordinates activities of outside contractors to ensure projects, maintenance and PM(s) are completed on time and correctly
  • Support validation of the equipment and systems
  • Maintains 100% on-time completion of PM’s and certifications
  • Plan and schedule the Boiler, Fire Extinguishers and Waste Management Annual PM and inspections
  • Responsible for equipment upgrades and completing necessary equipment change control documentation
  • Responsible for daily data logging/reviewing of the Environmental Monitoring System for Temperature and RH conditions
  • Other duties as assigned

 

Education and Experience Required:

Must have demonstrated knowledge of electrical and mechanical systems in a regulated environment.

  • Bachelor’s degree in Engineering, Mechanical, Industrial, Electrical
  • 3 year related pharmaceutical, biotech or medical devices
  • Facility /Industrial maintenance experience
  • Strong Technical Writing skills
  • Ability to manage multiple priorities and advance several tasks in parallel
  • Experience supervising, leading and mentoring technicians
  • Hands on experience with creation of SOPs, Work Order management