Utilities & Facilities Engineer

What We Are Looking For

The Utilities & Facilities Engineer is responsible for providing engineering, technical, and operational support for clean utilities, plant utilities, HVAC systems, and cleanroom infrastructure in a regulated pharmaceutical manufacturing environment. This role ensures systems are designed, maintained, and operated in compliance with GMP, safety, and regulatory requirements while supporting reliable site operations.

Your Role

• Provide technical guidance and field support to maintenance technicians and utility operators during maintenance, troubleshooting, and operational activities.
• Support day-to-day operation and maintenance of clean utilities (e.g., WFI, PW, RO, clean steam, compressed gases) and plant utilities (e.g., HVAC, chilled water, boilers, compressed air, vacuum).
• Serve as engineering support during system deviations, alarms, and operational challenges.
• Develop, review, and approve maintenance strategies for critical utilities and facilities systems, including PM optimization and reliability improvements.
• Collaborate with maintenance teams to define preventive and predictive maintenance requirements aligned with system criticality.
• Support spare-parts strategies and lifecycle planning for utilities assets.
• Act as engineering owner for cleanroom HVAC systems, including air handling units, pressure cascades, temperature, humidity, and airflow control.
• Responsible for HEPA filter certification, airflow velocity testing, and cleanroom environmental compliance.
• Support investigations and corrective actions related to HVAC and environmental excursions.
• Lead and support utilities and facilities projects, including system upgrades, remediation efforts, and capacity expansions.
• Coordinate with contractors, vendors, and internal stakeholders to ensure projects are executed safely, on schedule, and in compliance with GMP requirements.
• Participate in design reviews, risk assessments, and commissioning activities.
• Manage and support deviations, change controls, and CAPAs related to utilities and facilities systems.
• Ensure documentation and system operation adhere to ALCOA+ data integrity principles.
• Support regulatory inspections, audits, and internal quality reviews.
• Develop and deliver training programs for utility operators and maintenance technicians.
• Serve as engineering and facilities owner for the site pest control program.
• Coordinate with vendors to ensure program effectiveness, documentation accuracy, and GMP compliance.

Department Specific/Non-Essential Functions

• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and-or environmental incidents to management immediately.
• Support site emergency response related to utilities failures or facility issues.
• Support technical investigations and maintenance documentation updates.
• Collaborate with Quality, Validation, Production, and EHS for compliance initiatives.
• Participate in corporate or site-wide audits, CAPA reviews, and training sessions as required.
• Participate in cross-functional investigations and technical assessments.
• Other duties as assigned with or without accommodation

Your Background

• Bachelor’s Degree in Engineering (Mechanical, Electrical, Industrial, or related field) required.
• Master’s Degree preferred.
• Minimum of 5–10 years of experience in utilities and facilities engineering within a pharmaceutical, biotech, or regulated manufacturing environment.
• Demonstrated experience with clean utilities, HVAC systems, and GMP compliance.
• Proven experience in leading CAPA, change control, and compliance documentation processes.
• Strong understanding of GMP, FDA, and ISO regulations.
• Excellent analytical, organizational, and communication skills.
• Strong attention to detail and ability to manage multiple priorities.
• Proficient in Microsoft Office and Quality Management Systems (QMS).

Physical Requirements

• Ability to sit, stand, and walk for extended periods in an office and manufacturing environment.
• Frequently required to access mechanical spaces, utility rooms, or production areas (requiring PPE).
• Ability to climb ladders, access rooftops, and enter mechanical rooms.
• Ability to lift up to 30 pounds occasionally.
• Ability to wear required PPE, including cleanroom garments and respiratory protection when required.

Cognitive Requirements

• Strong analytical, problem-solving, and decision-making skills.
• Ability to interpret and apply complex regulations and quality standards.
• Ability to interpret technical drawings, P&IDs, specifications, and validation documentation.
• Capacity to manage multiple priorities and deadlines under minimal supervision.
• Effective written and verbal communication and critical thinking abilities.
• Excellent organizational, planning, and decision-making skills.
• Strong leadership and interpersonal communication skills.
• Capability to interpret engineering drawings, maintenance procedures, and regulatory requirements.
• Attention to detail and commitment to data integrity (ALCOA principles).

Working Conditions

• Normal office conditions but will spend significant time on the production floor and facilities/utilities area.
• On-site role in manufacturing plant environment
• May require occasional off-shift or weekend work to support manufacturing operations and projects
• Exposure to typical pharmaceutical production conditions, including cleanrooms, mechanical spaces, and utilities.
• Standard business hours with flexibility to support off-hour or weekend compliance activities as required.
• May be required to participate in audits or emergency responses outside of regular working hours.