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:
- Lead/execute production floor-based activities.
- Plan and execute C&Q, validation activities as required.
- Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
- Provide technical input into quality notification by authoring/reviewing/approving investigations.
- Execution of equipment/qualification validation programs; including re-qualification and re-validation
- Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
- Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
- Statistical data analysis to support development and commercialisation batches.
- Support continuous improvement through Lean Six Sigma methodologies
- Leading and active participation in projects, system failure investigations and investigation reports
- Execution/development of change controls
- 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
Requirements:
- Prior related work experience; ideally in manufacturing, preferably GMP Setting
- Typically have 5 years related work experience in Aseptic manufacturing / process engineering.
- Equipment and process validation
- Sterile filling processes and equipment
- Lean Six Sigma Methodology experience desired.
If this role is of interest to you, please apply now!
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