JOB DESCRIPTION SUMMARY

The Process engineer is responsible for ensuring that production infrastructure systems perform predictably and continue to operate as required to support the manufacturing process. The person will also be required to support the production processes by actively troubleshooting, developing and refining equipment.
The incumbent will also support Manufacturing in the implementation of process improvements and enhancements. This includes design, scope definition, change control and project management.
Reporting to the Technical Operations Manager.
GE Healthcare Ireland Ltd. manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. In 2023, our production volume was ca 40 mill units (vials) and supported turnover across the Supply chain of ~USD 550M. The plant has ~750 employees. As part of our ongoing journey to achieve our site vision of being a 50m unit (vials) capacity site, this role will play a key part in driving the necessary cultural and operational transformations to make this happen.

QUALIFICATIONS AND REQUIREMENTS

• Engineering degree in manufacturing, process, chemical engineering or related discipline.
• Basic engineering experience from development, process, or project work in pharmaceutical or process industry within an FDA approved environment.
• Good knowledge and experience of Technical Documentation, Engineering Standards, and Guidelines.
• Validation Lifecycle experience.
• Excellent written and oral communications skills and the ability to deal with a variety of people on a wide range of tasks.
• Must be good record keeper and results analyser.

• Ensuring all production equipment operates as per operational and validated requirements
• Monitoring Key Performance Indicators (KPI’s), analysing OEE, identifying trends, implementing corrective actions, implementing process improvements in a GMP environment.
• Project Management of small to medium sized site-specific capital projects through conception, approval, planning, execution, and validation in Production and Packaging areas.
• The development and execution of FAT, SAT and IOQ protocols.
• Work closely with other site functions to ensure a smooth transition between project and operational phases
• Management of and liaising with equipment vendors, contractors, project teams, and Business Unit.
• Troubleshooting and giving continuous technical support to specific processes in conjunction with the Maintenance, Packaging, and Quality Departments.
• Ensure that new plant equipment is included in the plant maintenance and calibration program
• Safety Champion of all production systems.
• Ownership of issues in the production equipment field. Eliminating re-occurring equipment problems
• Developing SOP’s, reliability procedures and management of change to equipment files. Assisting with generation, review and revision of maintenance documentation as necessary.
• Anticipating, solving or escalating problems as appropriate.
• Support the plant life cycle asset management process
• Providing technical assistance to maintenance personnel and other departments as required
• Risk assessments and mitigation projects relating to system performance.
• Representing technical support department on site-based teams involved in implementing new technology, products or business processes to the site.
• Continuous improvement programs and all performance improvement projects.
• Reviewing and approval of changes to operating procedures and the change control process relating to the system.
• Working in a collaborative manner within the Process Teams structure and contributes to investigations, NC and CAPA closure.
• Ensure all safety action (ATS, Concern Reports) assigned are actioned and closed in a satisfactory manner.
• Ensure that all health, safety & environmental requirements are fulfilled in accordance with the responsibilities defined in the company safety & environmental statements
• Play a leadership role in health, safety and environmental issues within the department.
• Strive for the highest standards in housekeeping and GMP
• Assist and lead CAPA investigations, determining accurate root cause and implementing action plans to prevent reoccurrences.
• Ensure all Quality Track wise actions that are assigned are actioned and closed in a satisfactory manner
• Aid the wider engineering group in the closure of Trackwise actions.