Job Description
We are seeking a Commissioning and Qualification Engineer to join our team at NIRAS Ireland.
Main Responsibilities:
* Generation, Execution and Approval of Qualification documents for Facility, Utility and Equipment systems
* Generation of Commissioning Test documents for non-direct Systems
* Commissioning and qualification of Clean Utilities Systems, including WFI Distillation, Storage and Distribution, Purified Water, POU Coolers, Partswasher, Sterilization Autoclave, VHP, Freezers, and Facility qualification
Requirements:
* 3 years of Commissioning and Qualification experience in a pharmaceutical or medical device manufacturing organization
* Kneat validation system knowledge is an advantage
* Proven track record working within a fast-paced GMP environment
* BS Degree in Engineering, Science or Technical discipline
* Experience with Clean Utilities, Hygienic Piping, Process Instrumentation, Controls and TOPs is mandatory
* Familiarity with risk-based approach to commissioning and qualification preferred
* Familiarity with project management tools advantageous
* Previous experience with Clean Utility tie-ins to existing systems is desirable
* Practical knowledge of Sanitary Equipment, Hygienic Piping, Process Instrumentation and Controls
* Adherence to cGMP and cGDP is mandatory
* Strong technical writing skills are essential
* Able to work independently with limited supervision – self-sufficiency is critical
* Demonstrable strong interpersonal & teamwork skills
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.