Job Description

Lead Critical Utility Systems in a GMP-Regulated Engineering Environment

Are you an experienced utilities engineer with hands-on knowledge of critical water and clean utility systems

Join a technically focused engineering team responsible for the reliable operation, maintenance and continuous improvement of essential utility infrastructure within a highly regulated manufacturing environment. This role offers the opportunity to take ownership of critical utility systems, lead technical investigations and contribute to engineering projects and system upgrades.

Key Responsibilities

Take ownership of critical utility systems, including Reverse Osmosis (RO), Water for Injection (WFI), clean steam and other associated clean utility systems.
Manage engineering change controls for utility-related projects, including the installation, modification or upgrading of RO and WFI equipment.
Oversee the operational performance, maintenance activities and reliability of critical utility equipment.
Lead investigations into utility-related deviations and document investigations through TrackWise or relevant quality systems.
Conduct detailed troubleshooting and root-cause analysis for equipment breakdowns, process abnormalities and recurring utility issues.
Recommend and implement appropriate corrective and preventive actions following technical investigations.
Provide engineering support for ongoing utility improvement, expansion and equipment-upgrade projects.
Work closely with relevant engineering, maintenance, quality and operations teams to ensure utility systems operate reliably and efficiently.
Ensure critical utility activities and engineering changes remain aligned with applicable GMP standards, procedures and regulatory expectations.
Monitor system performance and identify opportunities to improve equipment reliability, operational efficiency and compliance.

What We're Looking For

Degree in Engineering, Biomedical Engineering or a related technical discipline.
Approximately 4-10 years of relevant engineering experience in utilities, facilities, manufacturing or a regulated industrial environment.
Demonstrated hands-on experience with Reverse Osmosis (RO) systems is essential.
Practical knowledge of WFI, clean steam and other critical/clean utility systems.
Strong understanding of utility equipment operation, maintenance and performance monitoring.
Prior experience working within a GMP-regulated environment is essential direct pharmaceutical industry experience is not mandatory.
Strong troubleshooting, technical investigation and root-cause analysis capabilities.
Experience managing engineering projects, technical investigations and change-control activities.
Able to work independently, take ownership of technical issues and collaborate effectively with cross-functional stakeholders.
Strong documentation and communication skills, particularly when managing regulated engineering activities.