Description
Our global medical device client is currently seeking a Utilities/Facilities C&Q Engineer to manage and support the commissioning and qualification of Water for Injection (WFI) equipment such as pure steam generation, compressed air, HVAC, and other utilities/facilities for the Cork site.Main Responsibilities
- Generation and execution of the system commissioning protocols, installation & operation qualification protocols, process qualification protocols
- Responsible for the site remaining compliant with all relevant and up to date Utilities/Facilities policies and standards.
- Qualification & Validation of Water for Injection (WFI) equipment such as pure steam generation, compressed air, HVAC, and other utilities/facilities
- Responsible for the implementation of Utilities/Facilities best practice relevant to all Utilities Plant & Equipment to meet the requirements of the Sites Maintenance Excellence Program.
- Developing, maintaining, and reporting of Utilities performance metrics
Qualifications/Requirements
- Degree or equivalent in a relevant Engineering discipline.
- Strong Engineering experience in a pharmaceutical, process or regulated industry
- Strong experience in the facility and GMP utility commissioning and qualification
- Advanced knowledge of C&Q documentation required for cGMP process equipment.
- A strong working knowledge of site plant processes including Production, Packaging, QA, QC & Materials etc.