Utilities Operator

Role Summary

The Utility Operator is directly responsible for ensuring that the generation and distribution of utility services is provided without interruption to support the needs of the manufacturing facility. The role covers gray, clean, and plant utilities, performing direct execution of utility operations per SOPs and operating instructions to safely and compliantly support GMP manufacturing. During startup and project delivery phases (startup expected 2025–2027), roles will be fluid as the site builds processes, systems, and a culture to support GMP operations.

Responsibilities

• Ensure utility operations maintain compliance with all regulatory requirements at all times.
• Ensure utility areas appropriately support the execution of the production plan for the site.
• Utility Operator Systems: Water Systems, High Purity Water Generation, Boilers, Cooling Towers, Chillers (glycol/slytherm), Compressed Air Generation
• Carry out daily monitoring testing and cleaning duties as assigned on the above listed systems to ensure equipment and systems are in good operating condition and maintained in accordance with local and corporate regulatory requirements.
• Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards to execute key GMP duties.
• Understand other area processes & their operational hazards and respond appropriately.
• Monitor and collect data on equipment use and performance to anticipate potential reliability problems.
• Work with Maintenance and Technical Support to respond to potential utility upsets or equipment failure.
• Contact appropriate help if there is a problem or an event during processing.
• Communicate to other shifts regarding the status of area operations and details of issues at handover.
• Participate in building & area operations such as safety audits, procedure coordination, housekeeping, and improvement projects.
• Train and qualify on all specified unit operations within the building.
• Identify concerns for informal or formal discussion (crew meetings, safety representative).
• Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.

Qualifications

• Required: High School Diploma or equivalent
• Required: Legally authorized to work in the United States; no anticipated sponsorship for employment visa status
• Required: Experience in a manufacturing environment
• Required: Completion of Post Offer Exam or Work Simulation if applicable
• Preferred: Previous experience in facility/area startup environments
• Preferred: Previous experience in utility operations or directly supporting a pharmaceutical manufacturing operation
• Preferred: Basic computer skills (desktop software)
• Preferred: Understanding of FDA guidelines and cGMP requirements
• Preferred: Excellent interpersonal, written and oral communication skills
• Preferred: Strong organizational skills and ability to manage multiple requests
• Preferred: Knowledge of lean manufacturing principles
• Preferred: Emergency Response Experience (industrial, military, volunteer, career firefighter) or Indiana State/IFSAC Fire 1, Hazmat Technician certification

Skills

• Regulatory compliance and safety mindset
• Operational monitoring and data collection
• Problem solving and incident response
• Cross-functional communication and handover practices
• Maintenance coordination and basic technical troubleshooting

Education

• High School Diploma or equivalent

Additional Requirements

• Ability to work 12-hour day or night shifts
• Ability to work flexible schedules during startup period
• Ability to work overtime as required