This role is primarily within the NPI Technical Engineering team, supporting the New Product Introductions and ensuring compliance with global policies and cGMP
Job Summary
This role is primarily within the NPI Technical Engineering team, supporting the New Product Introductions and ensuring compliance with global policies and cGMP.
The specialist will lead and actively participate in projects, system failure investigations, and continuous improvement efforts using Lean Six Sigma methodologies.
The company values diversity and inclusion, aiming to invent solutions to meet unmet healthcare needs and drive innovation in the healthcare industry.
Matching Summary
This role is primarily within the NPI Technical Engineering team, supporting the New Product Introductions and ensuring compliance with global policies and cGMP.
Skills & Requirements
Must-have
Process and equipment validation
Lean Six Sigma methodologies
Good Manufacturing Practices (cGMP) compliance
Root cause analysis and corrective actions
Technical and validation support
Change control management
Equipment commissioning and qualification
Nice-to-have
Excellent communication and interpersonal skills
Cross functional team leadership
Knowledge of Irish, European and International regulatory codes
Sterile filling process experience
Participation in Kaizen events
Project management
Customer service orientation
Key Requirements
Bachelor’s Degree in Science, Engineering or Technical discipline
Experience in manufacturing preferably in a GMP setting
Knowledge of regulatory/code requirements to Irish, European and International standards