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 a significant investment has been undertaken to build a new cell culture green-field manufacturing site. Once built, this manufacturing site will be the largest single use biologics manufacturing plant globally and will employ around 400 staff. This site has been designed to run continuous bioprocessing, a next-generation manufacturing technology which will be implemented for the first time at this site. With this expansion, an exciting opportunity has arisen for a Process Engineer to join the organisation at the start-up phase in leading this business through construction and into manufacturing.
In this role, you will be involved in the design, construction and qualification activities for the upstream and downstream packages to enable start-up of the processing facility and for the ongoing process engineering activities during sustaining operations. The Process Engineer will be responsible for ensuring that all manufacturing process systems perform and operate as per their design. You will ensure that all systems conform to relevant regulatory requirements as well as company specifications and standards. The Process Engineer will support the implementation of both manufacturing process and utility/infrastructure changes including new system introductions and existing system improvements and enhancements. Other responsibilities will include:
- Managing the engineering equipment design - providing design and coordination support between the site and the package vendors
- During the project phase, being responsible for equipment tracking and managing the schedule from design through to system release to operations
- Ensuring all equipment and processes are safe, effective and in compliance with industry standards and regulatory expectations
- Authorship, review and approval of testing protocols and reports
- Responsible for project delivery, vendor enquires and the troubleshooting and monitoring of process systems
- Participating on project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release
- Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment or process performance
- Ensuring that new process systems are included in the plant maintenance and calibration program
- Project management of process system upgrades and modifications
The incumbent Process Engineer will have a minimum of 5 years' process engineering experience within high volume manufacturing within Biologics/Pharma sectors. A BEng/BSc in in Chemical or Process engineering is required.
As a Process Engineer, you will also have demonstrated expertise with the following:
- Commissioning and qualification of process equipment
- Providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment
- Experience in the qualification of GMP utilities and associated systems and processes
- Experience operating in a fully automated Delta V facility
- Equipment vendor package ownership and system design coordination
There are both permanent and contract positions available and come 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.