Process Engineer
The company is looking for a Process Engineer to support multiple capital projects taking place onsite in Leinster. This role involves leading/executing production floor-based activities, participating in a team of engineers, planning and executing C&Q, validation activities as required, designing & developing engineering studies, providing technical input into quality notifications, execution of equipment/qualification validation programs, performing data analysis, and making informed decisions/recommendations.
Key Responsibilities:
* Lead/execute production floor-based activities
* Participate on a team of engineers
* Plan and execute C&Q, validation activities as required
* Design & develop engineering studies
* Provide technical input into quality notification by authoring/reviewing/approving investigations
* Execution of equipment/qualification validation programs; including re-qualification and re-validation
* 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
* Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
Requirements:
* Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
* Prior related work experience; ideally in manufacturing, preferably GMP Setting
* Typically have 5 years related work experience in Aseptic manufacturing / process engineering
* Knowledge of regulatory/core requirements to Irish, European and International Codes, Standards and Practices
* Report, standards, policy writing skills required
* Equipment and process validation
* Sterile filling processes and equipment
* Proficiency in Microsoft Office and job-related computer applications required
* Lean Six Sigma Methodology experience desired