Commissioning and Qualification Engineer
We are seeking a proactive and hands-on Commissioning and Qualification Engineer to assist in the implementation of New Clean Utilities Systems.
About the Role
* 3 years of Commissioning and Qualification experience, preferably in a pharmaceutical or medical device manufacturing organization.
* Familiarity with Kneat validation system is an advantage.
* Proven track record working within a fast-paced GMP environment.
* BS Degree in Engineering, Science, or Technical discipline.
Main Responsibilities
1. Generation, Execution, and Approval of Qualification documents for Facility, Utility, and Equipment systems.
2. Generation of Commissioning Test documents for non-direct Systems at our clients advanced Aseptic Sterile Manufacturing, Biologics site in Westport.
Main Systems in Scope
* WFI Distillation, Storage, and Distribution.
* Purified Water.
* POU Coolers.
* Partswasher.
* Sterilization Autoclave.
* VHP.
* Freezers.
* Facility qualification.
About Us
NIRAS Ireland specializes in design and delivery of process-driven projects. We provide Project Management, Engineering Design, Project, and Managed Service resources to the Life Science, Food & Beverage, and Advanced Process Manufacturing sectors across Ireland and internationally.