Utilities & Facilities Engineer M/F (30535)

Laboratoire Guerbet•Raleigh, IL

25d•Onsite

About The Position

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.The engineer collaborates closely with utility operators, maintenance technicians, Quality, EHS, and Production to support troubleshooting, maintenance execution, capital projects, and continuous improvement initiatives.

Requirements

Bachelor’s Degree in Engineering (Mechanical, Electrical, Industrial, or related field) required.
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).
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.
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).

Nice To Haves

Master’s Degree preferred.

Responsibilities

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.
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