Website Goodwin Biotechnology
Job Description – Facilities and Utilities Engineer
Scope of Function: Provides engineering support for the clean room utility and process systems, Plant steam boiler, HVAC, Purified Water System, Process chillers, Air Compressors, Sterilizers, Bioreactors, Refrigerators and Incubators, including preventative maintenance and equipment qualification support. Generates and maintains all the documentation of the executed preventive and corrective maintenance and prepare summary reports as required for the monthly PM schedule. Complies with all regulatory / cGMP guidelines, standards, and policies.
Reports to: Associate Director of Facilities and Engineering
- 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.
- Establish/maintain key performance indicators.
- 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.
Education and Skills Required:
Associate or Bachelor of Science in Engineering, Instrumentation or Electronics. 1 – 2 years related pharmaceutical or facility maintenance experience. Five (5) or more years pharmaceutical or biotechnology manufacturing experience. Strong Technical Writing skills. Ability to manage multiple priorities and advance several tasks in parallel. Proficient in use of Microsoft Word and Excel. Hands on experience on utility systems and Work Order management. Ability to define problems, collect data, establish facts, and draw valid conclusions. Experience supervising activities of maintenance personnel. Automation, PLC (Allen Bradley, HMI’s, RS Logix, Siemens). Working knowledge of Reliability Centered Maintenance (RCM). Experience with Computer Maintenance Management Systems (SAP, Blue Mountain, Master Control or Maximo).
Interact with Manufacturing, Process Development, QC and QA at Goodwin Biotechnology and outside contractors and government agencies.