Shift Process Engineer - Exciting Opportunity in Leinster, Ireland.
Our client is a global pharmaceutical company seeking a Shift Process Engineer to join their team in Carlow. This is an exceptional opportunity to work on state-of-the-art facilities and contribute to the development of new products.
Key Responsibilities:
• Design, author, review, approve, and execute process simulations studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notifications by authoring, reviewing, and approving process simulation-related investigations.
• Design, author, review, approve, and execute commercial and process simulation qualification/validation documentation and studies in line with the standard approval process.
• Perform data analysis and make informed decisions/recommendations based on conclusions reached from data analysis.
• Support continuous improvement through Lean Six Sigma methodologies.
• Lead and actively participate in projects, system failure investigations, and investigation reports.
• Execute/develop change controls to support the Process Simulation process.
• Contribute 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 a 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.