Job Title: Infrastructure Systems Specialist
A skilled professional will be responsible for ensuring seamless operation of clean and plant utility systems, encompassing water supply, steam generation, heating, ventilation, and gas delivery.
The role involves overseeing the performance, maintenance, and calibration of utility equipment to ensure adherence to current Good Manufacturing Practices (cGMP) and regulatory standards.
Critical parameters such as Total Organic Carbon (TOC), conductivity, temperature, pressure, differential pressure, etc., will be monitored and responded to in a timely manner.
Prioritizing sterility and microbial control is essential, aligning with FDA, EMA, and WHO guidelines.
Maintaining accurate documentation, participating in audits, and driving continuous improvement initiatives are key responsibilities.
This senior position requires substantial experience in infrastructure or facilities engineering within sterile or aseptic pharmaceutical manufacturing environments, specifically 35 years.
* Bachelor's degree in Mechanical, Chemical, or Electrical Engineering (or related discipline)
* Proven expertise in clean utility systems
* Familiarity with GMP, FDA/EMA regulations, and Annex 1
Please contact Louise Mulligan for more information on this opportunity.