Utilities & Facilities Engineer

About the role

The Utilities and Facilities Engineer provides technical leadership for clean utilities, plant utilities, and facility systems in a highly regulated manufacturing environment. This role supports day-to-day operations, leads troubleshooting and maintenance optimization, and ensures that HVAC, cleanroom, and utilities systems operate reliably and in full compliance with GMP and relevant regulatory standards. The engineer also drives continuous improvement projects, manages compliance documentation, and collaborates across functions to maintain a safe, efficient, and inspection-ready site.

Responsibilities

• Provide technical guidance and field support to maintenance technicians and utility operators during maintenance, troubleshooting, and operational activities.
• Serve as engineering support during system deviations, alarms, and operational issues, driving timely resolution and root cause analysis.
• Develop, review, and approve maintenance strategies for critical utilities and facility systems, including preventive maintenance optimization and reliability improvements.
• Collaborate with maintenance teams to define preventive and predictive maintenance requirements aligned with system criticality and regulatory expectations.
• Support spare-parts strategies and lifecycle planning for utilities assets to ensure availability and long-term reliability.
• 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, maintaining accurate, complete, and traceable records.
• Support regulatory inspections, external audits, and internal quality reviews by providing technical expertise and documentation.
• 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 GMP-compliant documentation.
• Coordinate with pest control vendors to maintain program performance, documentation accuracy, and regulatory compliance.
• Support site emergency response related to utilities failures or facility issues, providing technical direction and corrective action plans.
• Support technical investigations and updates to maintenance documentation, procedures, and standards.
• Collaborate closely with Quality, Validation, Production, and EHS teams on compliance initiatives and continuous improvement activities.
• Interpret engineering drawings, P&IDs, specifications, and validation documentation to guide maintenance, troubleshooting, and project work.

Requirements

• Minimum of 5–10 years of experience in utilities and facilities engineering within a pharmaceutical, biotech, or other regulated manufacturing environment.
• Demonstrated experience with clean utilities, HVAC systems, and GMP-compliant operations.
• Proven experience in leading CAPA, change control, and compliance documentation processes for utilities and facility systems.
• Strong understanding of GMP, FDA, and ISO regulations and their application to utilities, cleanrooms, and facility operations.
• Ability to interpret technical drawings, P&IDs, specifications, and validation documentation accurately and effectively.
• Strong understanding of ALCOA and ALCOA+ data integrity principles and their application to maintenance and operational records.
• Hands-on experience with cleanroom environments, HVAC controls, HEPA filtration, and airflow testing.
• Experience with WFI (Water for Injection) systems, cleanroom operations, and utilities in a regulated setting.
• Proficiency in managing deviations, change controls, and CAPAs within Quality Management Systems (QMS).
• Excellent analytical, problem-solving, and decision-making skills for complex technical and compliance issues.
• Effective written and verbal communication skills to collaborate with cross-functional teams and present technical information clearly.
• Strong leadership and interpersonal communication skills to guide technicians, operators, and project stakeholders.
• Capability to interpret and apply complex regulations, quality standards, and engineering requirements to daily operations.
• Attention to detail and a strong commitment to data integrity and accurate documentation.
• Proficient in Microsoft Office applications for analysis, reporting, and documentation.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Electrical, Industrial, or related field) required.
• Master's degree in Engineering or a related discipline preferred.
• Excellent organizational, planning, and time-management skills with the ability to manage multiple priorities and deadlines under minimal supervision.
• Strong critical thinking abilities to assess risk, evaluate options, and recommend effective solutions.
• Capacity to work collaboratively with Quality, Validation, Production, EHS, and external partners.
• Experience participating in design reviews, risk assessments, commissioning, and qualification activities is highly beneficial.
• Familiarity with Quality Management Systems (QMS) and electronic documentation tools.
• Demonstrated ability to lead training sessions and mentor maintenance technicians and utility operators.
• Experience coordinating with vendors and contractors for projects, maintenance, and pest control programs.
• Commitment to continuous personal development and staying current with industry standards and best practices.

Pay and Benefits

The pay range for this position is $100,000.00 - $120,000.00/yr. Full company benefits include PTO, holiday, medical, dental, vision, 401(k), bonus.

Workplace Type

This is a Permanent position based out of Raleigh, NC.

Application Deadline

This position is anticipated to close on Jul 24, 2026.