Shift Process Engineer - 11 Month Contract + Possible Extensions - Carlow, Ireland
With increasing worldwide demand for their life-changing oncology treatments, one of our global pharmaceutical clients is seeking a Shift Process Engineer to join their team. The role involves supporting multiple capital projects onsite in Leinster.
This is a fantastic opportunity to work at a state-of-the-art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
Role Summary:
1. Design, author, review, approve, and execute process simulation studies supporting new product introduction and manufacturing.
2. Provide technical input into quality notifications by authoring, reviewing, and approving process simulation-related investigations.
3. Design, author, review, approve, and execute qualification and validation documentation and studies for commercial and process simulations in line with approval processes.
4. Perform data analysis and provide informed recommendations based on conclusions.
5. Support continuous improvement initiatives using Lean Six Sigma methodologies.
6. Lead and participate in projects, system failure investigations, and report generation.
7. Develop and execute change controls to support process simulation activities.
8. Contribute to Kaizen events as appropriate.
9. Conduct root cause analyses of system failures or substandard performance using tools like FMEA, Fishbone diagrams, and 5 Whys.
10. Implement corrective actions through the change management system.
11. Represent technical engineering in internal discussions and global technical forums related to process simulations.
Role Requirements:
1. Bachelor’s Degree or higher, preferably in Science, Engineering, or a related technical discipline.
2. Knowledge of regulatory and code requirements in Irish, European, and international standards.
3. Experience in report writing, standards, and policy development.
4. Experience with equipment and process validation.
5. Knowledge of sterile filling processes and equipment.
6. Proficiency in Microsoft Office and related applications.
7. Lean Six Sigma experience is desirable.
If this role interests you, please apply now!
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