A Utilities Engineer is required by CareerWise Recruitment for our Mayo based pharmaceutical client. This is a 12-24 month contract. You will be responsible for clean and plant utility systems critical to aseptic production environments, such as Water for Injection (WFI), Clean Steam, HVAC for classified areas, and Compressed Gases.
THE ROLE
* Ensure uninterrupted, validated, and compliant operation of clean and plant utility systems, including:
o Clean Utilities: Purified Water (PW), Water for Injection (WFI), Clean Steam, Clean Compressed Air, Process Gases (e.g., Nitrogen)
o Plant Utilities: Chilled Water, HVAC Systems, Boilers, Steam, Compressed Air, Vacuum Systems
* Oversee the performance, maintenance, and calibration of utility equipment, ensuring adherence to cGMP and regulatory standards.
* Monitor critical parameters (TOC, conductivity, temperature, pressure, differential pressure, etc.) and respond promptly to deviations or excursions.
* Support and/or lead qualification and requalification activities for utility systems (IQ/OQ/PQ).
* Ensure utilities meet sterility and microbial control requirements per FDA, EMA, and WHO guidelines.
* Maintain accurate and up-to-date documentation: P&IDs, URS, FAT/SAT protocols, SOPs, and validation reports.
* Participate in internal and external audits, inspections, and regulatory reviews related to utilities.
* Drive continuous improvement initiatives to enhance system reliability, energy efficiency, and cost-effectiveness.
* Lead or support capital projects related to utility expansions, upgrades, or new installations.
* Analyze utility performance data and implement improvements to minimize downtime and energy consumption.
* Support investigations for deviations, non-conformances, and out-of-specification results related to utility systems.
REQUIREMENTS
* Bachelor’s degree in Mechanical, Chemical, or Electrical Engineering (or related discipline).
* 3–5 years of experience in utilities or facilities engineering within a sterile or aseptic pharmaceutical manufacturing environment.
* Proven expertise in clean utility systems (WFI, Clean Steam, HVAC for Grade A/B areas).
* Strong knowledge of GMP, FDA/EMA regulations, and Annex 1 (sterile manufacturing requirements).
* Familiarity with steam sterilization systems, autoclaves, and cleanroom HVAC design is a strong advantage.
Please call Louise Mulligan today for further information on or email:
CareerWise Recruitment (In Search of Excellence)
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