Process Engineer - Pharmaceuticals - 11-Month Contract
With the demand for their life-changing oncology treatment increasing worldwide, one of our global pharmaceutical clients is seeking a Process Engineer to support multiple capital projects on site in Carlow.
This presents an excellent opportunity to work on a cutting-edge fill-finish facility and the company's first standalone 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 notifications 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).
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.