This role provides technical leadership and hands-on support for clean utilities, plant utilities, and facilities systems in a regulated manufacturing environment. The Utilities and Facilities Engineer ensures reliable operation of critical systems such as cleanroom HVAC, water for injection, and other utilities while maintaining strict compliance with GMP, FDA, and ISO requirements. The position combines field-based troubleshooting, engineering ownership, project leadership, and quality documentation to support safe, efficient, and compliant manufacturing operations.

• 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 and plant utilities, ensuring reliable and compliant performance.
• Serve as engineering support during system deviations, alarms, and operational issues, helping to diagnose root causes and implement effective solutions.
• Develop, review, and approve maintenance strategies for critical utilities and facilities systems, including preventive maintenance optimization and reliability improvements.
• Collaborate with maintenance teams to define preventive and predictive maintenance requirements aligned with system criticality and risk.
• Support spare-parts strategies and lifecycle planning for utilities assets to minimize downtime and ensure continuity of operations.
• Act as engineering owner for cleanroom HVAC systems, including air handling units, pressure cascades, temperature, humidity, and airflow control.
• Oversee and ensure HEPA filter certification, airflow velocity testing, and overall cleanroom environmental compliance.
• Support investigations and corrective actions related to HVAC and environmental excursions, ensuring timely resolution and documentation.
• 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 for utilities and facilities systems.
• Manage and support deviations, change controls, and CAPAs related to utilities and facilities systems, ensuring accurate and timely documentation.
• Ensure documentation and system operation adhere to ALCOA+ data integrity principles.
• Support regulatory inspections, external audits, and internal quality reviews related to utilities, facilities, and environmental controls.
• Develop and deliver training programs for utility operators and maintenance technicians on systems, procedures, and compliance requirements.
• Serve as engineering and facilities owner for the site pest control program, ensuring program effectiveness and regulatory compliance.
• Coordinate with pest control vendors to maintain accurate documentation and ensure GMP-compliant execution of the program.
• Support site emergency response related to utilities failures or facility issues, including troubleshooting and coordination of corrective actions.
• Support technical investigations and updates to maintenance documentation, procedures, and technical records.
• Collaborate closely with Quality, Validation, Production, and EHS teams to support compliance initiatives and continuous improvement.
• Contribute to a culture of safety, quality, and continuous improvement within the utilities and facilities function.

• 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, including systems such as WFI and related critical utilities.
• Proven experience with HVAC systems, including cleanroom environmental controls and air handling units.
• Demonstrated experience in leading CAPA, change control, and compliance documentation processes.
• Strong understanding of GMP regulations and their application in a manufacturing environment.
• Strong understanding of FDA and ISO regulations relevant to pharmaceutical or regulated manufacturing.
• Ability to interpret technical drawings, P&IDs, specifications, and validation documentation.
• Strong understanding of ALCOA and ALCOA+ data integrity principles and their practical application.
• Proficient in Microsoft Office applications for documentation, analysis, and reporting.
• Experience working within Qua