Job Title: Process Engineer (Shift)
Location: Carlow, Ireland
About the Role:
We are seeking a highly skilled and experienced Process Engineer to join our team at an award-winning Pharmaceutical organization in Carlow. As a key member of our technical operations team, you will be responsible for providing technical support for manufacturing and new product introduction.
Key Responsibilities:
* Technical support for manufacturing and new product introduction
* Design and execution of process simulations studies in support of new product introduction and ongoing manufacturing support
* Technical input into quality notifications by authorizing, reviewing, and approving Process Simulation related investigations
* Design and execution of commercial and process simulation qualification/validation documentation and studies in line with standard approval processes
* Data analysis and informed decision-making around conclusions reached from data analysis
* Supporting continuous improvement through Lean Six Sigma methodologies
* Leading and participating in projects, system failure investigations, and investigation reports
* Execution and development of change controls to support the Process Simulation process
* Contribution to Kaizen events as appropriate
* Root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
* Implementation of subsequent corrective action through the change management system
* Representation of technical operations at global technical forums in relation to process simulations
* Participation and/or leadership of cross-functional or single-function teams, including liaison with vendors or other site groups
Requirements:
* Bachelor's Degree or higher in a Science, Engineering, or other Technical field
* Experience in an Aseptic sterile manufacturing environment preferred
* Strong knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environments