Job Title: Shift Process Engineer
Shift Process Engineer - 11 Month Contract + Possible Extensions in Carlow, Ireland.
With the global demand for their life-changing oncology treatment increasing, one of our pharmaceutical clients is seeking a Shift Process Engineer to join their team and support multiple capital projects on-site in Leinster. This opportunity involves working 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:
* Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support.
* Provide technical input into quality notifications by authoring/reviewing/approving Process Simulation related investigations.
* Design/Author/Review/Approve/Execute commercial & process simulation 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.
* 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 to support the Process Simulation process.
* Contribution to Kaizen events as appropriate.
* 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.
* Implement subsequent corrective action through the change management system.
* Serve as technical engineering representative for internal technical group discussions and represent technical operations Carlow 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.