This leading global biologics organisation provides comprehensive integrated and customisable services to the biopharmaceutical and related industry sectors from contract development services to contract manufacturing services. Recently, this business has announced expansions into regions such as the U.S and Ireland, where significant investment has been undertaken to build a new green-field manufacturing site. With this expansion, an exciting opportunity has arisen for a Clean Utilities Engineer to join the organisation at the start-up phase in leading this business through construction and into manufacturing.
The Clean Utilities Engineer will own, control and manage the clean utility systems throughout the facility to deliver a system capable of safe and continuous supplies to all points and users without interruption or impact. You will be fully responsible for CA, CS, PW, WFI, loop and CIP/SIP and implement planning and distribution for PM work orders and initiate operation plan.
In addition, you will:
- Be involved in the clean utility URS, installation and construction supervision, co-leading C&Q, support on PQ, calibration activities.
- Initiate and revise SOP for CU system, monitor execution of SOP in EHS and GMP area, and implement training to ensure operation staff activities followed by SOP. Deal with problems during operation.
- Implement validation and qualification for CU system according to company standards and GMP requirement.
- Initiate proper material and spare part plan for above CU system.
The Clean Utilities Engineer will have a minimum of 5 years' experience within a highly regulated industry. A 3rd Level Technical qualification in Engineering is required.
As the Clean Utilities Engineer, you will also have demonstrated expertise within the following areas:
- Strong experience within utility systems within a highly regulated sector.
- Thorough knowledge of safety, GMP and environmental regulatory requirements around site utilities systems
- Demonstrated capability within an Audit environment (specifically EHS and GMP).
- Strong Communication and Leadership skills.
This is a permanent position and comes with an excellent package along with superb working conditions.
To discover more about this opportunity, apply now or contact James Colbert at HRM on +353 1 6321840 for a confidential discussion.