Sr. Utility Engineer

About the Role

The Sr. Utility Engineer is responsible for operating, maintaining, and improving process/plant utilities and systems that support all Ohio American Regent facilities. Scope includes industrial systems such as plumbing, plant steam, power distribution, cooling systems, compressed air, gases, heating hot water, chilled water, and all clean utilities (steam, WFI, Purified Water, RO/EDI). The incumbent has responsibility for indirectly supervising and directing internal resources as well as contract service providers and will serve as the Subject Matter Expert (SME) for all utilities systems.

This position requires developing, following, and maintaining procedures to ensure utility systems adhere to cGMPs, company, local, and state requirements, including health and safety standards. The Sr. Utility Engineer must manage multiple tasks, projects, and procurement while ensuring compliance in an FDA-regulated environment. This is a hands-on role supporting aseptic manufacturing and packing operations, requiring strong communication, leadership, and the ability to present to leadership teams.

Responsibilities

• Lead Capital Projects:
  • Develop scope, budget, and User Requirement Specifications (URS) and manage all project phases to completion.
  • Coordinate process utility support activities such as equipment reconfiguration, changeover, and replacement planning.
  • Support factory acceptance of equipment; review specifications, drawings, and submittals.
  • Develop and maintain up-to-date drawings of new and/or existing equipment, systems, and processes.
  • Coordinate handover from Engineering to Maintenance and Operations.
  • Work with the engineering team to review specifications and provide input.
  • Accept turnover packages and establish maintenance programs.
  • Support qualification activities, including protocol generation, review, and execution.
• Optimize Utilities:
  • Perform capacity analysis of each system and recommend improvements.
  • Review, modify, and develop operating and preventive maintenance procedures for utilities and systems.
  • Develop and review metrics on utility systems.
  • Create schedules for preventive maintenance and support shutdown activities.
  • Evaluate breakdown statistics and adjust maintenance plans accordingly.
  • Increase utility equipment availability through reduction of breakdowns.
  • Assist with engineering design and troubleshooting for reliable, safe, and efficient operations.
  • Support Quality Assurance investigations of utility issues.
  • Acquire, organize, and analyze data to reach accurate conclusions using statistical methods.
  • Facilitate completion of change control documentation.
  • Develop training modules and provide coaching/feedback to enhance technical personnel capabilities.
  • Provide technical troubleshooting support to mechanics responding to breakdowns.
• Additional Duties:
  • Perform any other tasks/duties as assigned by management.
  • Role models a "can-do" attitude, adaptability, and responsiveness.
  • Clearly and concisely express thoughts in written procedures, protocols, and reports.
  • Generate presentations/reports to explain and analyze areas of responsibility.

Requirements

• Bachelor’s Degree in Engineering or equivalent years of related experience.
• Minimum of 7 years of manufacturing facility engineering experience.
• Minimum 4 years of experience with Clean Utility systems and equipment (e.g., filters, ion exchange, Reverse Osmosis, multi-effect stills, clean steam generators).
• Experience with Plant Utility systems and equipment (e.g., vacuum pumps, compressors, chillers, boilers).
• Experience with HVAC systems (e.g., air handlers, chillers, heat exchangers).
• Ability to size and specify utility equipment.
• Experience coordinating large-scale shutdowns/turnarounds.
• Ability to understand mechanical layouts and electrical/pneumatic schematics (P&IDs).
• Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing.
• Proficiency in Microsoft Office Applications (Microsoft Project, Word, Excel).
• Understanding of engineering principles as they apply to facility and production equipment.
• Hands-on ability to isolate problems and identify root causes.
• Comfortable working in a production environment with multiple priorities; effective as a team member or leader.
• Strong oral and written communication skills, attention to detail, and excellent time/project management skills.
• Ability to handle multiple priorities in a fast-changing work environment.
• Creative thinker with strong interpersonal, project management, and process improvement skills.
• Ability to coordinate and resolve both interpersonal and technical problems; work independently.

Preferred Qualifications

• 5 years’ experience in pharmaceutical or a regulated similar industry.
• 5 years of maintenance experience.
• Experience with regulatory interaction/auditing.
• Experience with Validation and Investigation Reporting.

Physical Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including gowns, goggles, face shields, and protective gloves.
• Must be able to occasionally lift and/or move up to 15 pounds.