Shift Process Engineer - 11 Month Contract + Possible Extensions - Carlow, Ireland
With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Shift Process Engineer to join their team to support multiple capital projects taking place onsite in Leinster.
This is a fantastic opportunity to work on 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/Execute process simulations studies in support of new product introduction and ongoing manufacturing support.
2. Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations.
3. Design/Author/Review/Approve/Execute commercial & process simulation qualification/validation documentation and studies in line with the standard approval process.
4. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
5. Support continuous improvement through Lean Six Sigma methodologies.
6. Leading and active participation in projects, system failure investigations and investigation reports,
7. Execution/development of change controls to support the Process Simulation process.
8. Contribution to Kaizen events as appropriate.
9. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc.
10. Implement subsequent corrective action through the change management system.
11. Serve as technical engineering representative for internal technical group discussions and represent technical operations Carlow at global technical forums in relation to process simulations.
Role Requirements:
12. Bachelor's Degree or higher preferred; ideally in a Science, Engineering, or other Technical Discipline
13. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
14. Report, standards, policy writing skills required.
15. Equipment and process validation
16. Sterile filling processes and equipment
17. Proficiency in Microsoft Office and job-related computer applications required.
18. Lean Six Sigma Methodology experience desired.
If this role is of interest to you, please apply now
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