Exciting pharmaceutical projects beckon your expertise!
About the Opportunity
Our esteemed client, a leading Centre of Excellence in veterinary vaccine production, is expanding its team. As a Shift Process Engineer, you'll contribute to the development and production of innovative veterinary vaccines at their largest centre worldwide.
Responsibilities:
* Design, author, review, approve, and execute process simulations studies for new product introductions and ongoing manufacturing support.
* Provide technical input into quality notifications by authorizing, reviewing, and approving Process Simulation-related investigations.
* Develop commercial and process simulation qualification/validation documentation and studies aligned with standard approval processes.
* Analyze data and make informed decisions or recommendations based on conclusions drawn from data analysis.
* Promote continuous improvement through Lean Six Sigma methodologies.
* Lead and participate in projects, system failure investigations, and investigation reports.
* Execute and develop change controls to support the Process Simulation process.
* Contribute to Kaizen events as needed.
* Analyze system failures, substandard performance, and implement corrective actions using standard tools and methods (e.g., FMEA, Fishbone diagrams, 5 whys).
* Serve as a technical engineering representative in internal discussions and represent technical operations Carlow at global forums related to process simulations.
* Participate in cross-functional or single-function teams, liaising with vendors or above-site groups.
* Ensure compliance with Merck Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) in daily activities and job functions.
* Collaborate to drive a safe and compliant culture in Carlow.
Requirements:
* Knowledge of regulatory/code requirements for Irish, European, and International Codes, Standards, and Practices.
* Report, standards, policy writing skills.
* Equipment and process validation expertise.
* Familiarity with sterile filling processes and equipment.
* Proficiency in Microsoft Office and relevant computer applications.
* Desirable experience in Lean Six Sigma Methodology.
* Background in Aseptic sterile manufacturing environments preferred.
* Able to coach and lead change effectively.
* Strong knowledge of sterile manufacturing processes, focusing on delivery and results in highly regulated environments.