This is an exciting opportunity to work on a state-of-the-art fill-finish facility and contribute to the development of cutting-edge pharmaceutical products.
Key Responsibilities:
* To design, author, review, approve and execute process simulations studies in support of new product introduction and ongoing manufacturing support.
* To provide technical input into quality notifications by authorizing/reviewing/approving Process Simulation related investigations.
* To design, author, review, approve and execute commercial & process simulation qualification/validation documentation and studies in line with the standard approval process.
* To perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
* To support continuous improvement through Lean Six Sigma methodologies.
* To lead and actively participate in projects, system failure investigations and investigation reports.
* To execute/develop change controls to support the Process Simulation process.
* To contribute to Kaizen events as appropriate.
* To 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 why's etc.
* To implement subsequent corrective action through the change management system.
* To serve as a technical engineering representative for internal technical group discussions and represent technical operations at global technical forums in relation to process simulations.
Requirements:
* Bachelor's Degree or higher preferred; ideally in a Science, Engineering, or other Technical Discipline.
* Knowledge of regulatory/code 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.