Job Opportunity
This is a fantastic opportunity to work on a state-of-the-art fill-finish facility and a cutting-edge vaccine and biologics plant.
* 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 whys etc.
* Implement subsequent corrective action through the change management system.
* Serve as technical engineering representative for internal technical group discussions and represent technical operations at global technical forums in relation to process simulations.