We are seeking a Utilities Engineer SME to join a leading pharmaceutical client in Dublin on a 12-month contract. This role will serve as a System Owner for key clean and black utility systems across the site, including WFI, gas, chemical, refrigeration, and other critical utility infrastructure. The successful candidate will act as the technical authority for their assigned systems, ensuring operational readiness, compliance, and continuous improvement.
This is a fully onsite role suited to candidates who thrive in a hands-on, collaborative manufacturing environment.
Key Responsibilities:
- Act as System Owner for assigned clean and black utility systems, ensuring full lifecycle management from design through operation and continuous improvement.
- Ensure systems comply with GMP, EHS, global engineering standards, and local regulatory requirements.
- Support manufacturing, QC, and audit readiness activities through subject matter expertise.
- Lead and resolve deviations, perform root cause analysis, and implement CAPAs.
- Develop and review User Requirements Specifications (URS) and support equipment installation and qualification.
- Maintain and optimize asset data in the CMMS, including PMs, PdMs, calibration schedules, spare parts, and job plans.
- Collaborate with the maintenance department, providing technical direction and reviewing vendor maintenance reports.
- Own all associated change controls and ensure proper documentation and system updates.
- Define and track performance metrics such as uptime, running cost, and energy efficiency.
- Prepare budgets and support capital projects, including scope development and project execution for assigned systems.
- Participate in internal and external audits as the Utilities SME.
- Promote a culture of continuous improvement and compliance across all utility operations.
Essential Skills & Experience:
- Proven experience in utility systems such as WFI, gas systems, bulk chemicals, freezers, fridges, and related clean/black utility infrastructure.
- Strong understanding of GMP, cGDP, regulatory compliance, and system qualification requirements.
- Experience working as a system or equipment owner in a regulated pharmaceutical or biopharmaceutical environment.
- Familiarity with CMMS, reliability-centered maintenance, and performance metrics tracking.
- Experience supporting audits and regulatory inspections.
- Strong troubleshooting, analytical, and documentation skills.
Qualifications:
- Bachelor's degree (Level 8 or higher) in an Engineering discipline.
- Minimum of 4+ years of relevant experience in a pharmaceutical utilities or maintenance engineering role with system ownership experience.