Job Summary
We are seeking a highly skilled Process Engineering Specialist to join our operations team in Carlow, Ireland. As a key member of the team, this individual will be responsible for supporting multiple capital projects at our state-of-the-art fill-finish facility and first stand-alone vaccine and biologics plant outside the US.
Key Responsibilities:
* Process Development: Design, author, review, approve, and execute process simulations studies to support new product introduction and ongoing manufacturing support.
* Quality Assurance: Provide technical input into quality notifications by authorizing, reviewing, and approving Process Simulation related investigations.
* Documentation: Develop commercial and process simulation qualification/validation documentation and studies in accordance with standard approval processes.
* Data Analysis: Analyze data and make informed decisions/recommendations based on conclusions reached from data analysis.
* Continuous Improvement: Support continuous improvement through Lean Six Sigma methodologies.
* Project Leadership: Lead and participate in project teams, system failure investigations, and investigation reports.
* Change Management: Execute change controls to support the Process Simulation process.
* Kaizen Events: Contribute to Kaizen events as appropriate.
* Troubleshooting: Perform root cause analysis of system failures, substandard performance, using standard tools and methods to resolve machine and system issues.
* Corrective Action: Implement subsequent corrective action through the change management system.
Requirements:
* A 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 experience.
* Proficiency in Microsoft Office and job-related computer applications.
* Lean Six Sigma Methodology experience desired.
This is an excellent opportunity to work with a leading pharmaceutical company and contribute to the development of life-changing treatments. If you are a motivated and experienced engineer looking for a new challenge, we encourage you to apply now.