Process Engineer - Pharmaceuticals - 11-Month Contract
We are seeking a skilled Process Engineer to support multiple capital projects at our site in Carlow, Ireland. This is an exciting 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.
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.
The estimated salary for this position is €70,000 - €90,000 per year, depending on experience.