Process Engineer - Pharmaceuticals - 11-Month Contract
With worldwide demand for their life-changing oncology treatment increasing, one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Carlow.
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. Lead/execute production floor-based activities.
2. Plan and execute C&Q, validation activities as required.
3. Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
4. Provide technical input into quality notification by authoring/reviewing/approving investigations.
5. Execution of equipment/qualification validation programs; including re-qualification and re-validation.
6. Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
7. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
8. Statistical data analysis to support development and commercialisation batches.
9. Support continuous improvement through Lean Six Sigma methodologies.
10. Leading and active participation in projects, system failure investigations and investigation reports.
11. Execution/development of change controls.
12. 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.
Requirements:
1. Prior related work experience; ideally in manufacturing, preferably GMP Setting.
2. Typically have 5 years related work experience in Aseptic manufacturing / process engineering.
3. Equipment and process validation.
4. Sterile filling processes and equipment.
5. Lean Six Sigma Methodology experience desired.
If this role is of interest to you, please apply now!
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