Job Summary
Our client, a privately owned Irish company based in Longford, is seeking to recruit an ambitious Validation Engineer. This is a hands-on role within a dynamic manufacturing environment.
Key Responsibilities:
* Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge.
* Developing and implementing solutions to sustain and improve the Quality Management System (QMS).
* Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
* Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
* Generation of risk assessments, covering cleaning, validation, and process.
* Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
* Directly supports Good Manufacturing Practice (GMP) and regulatory audits.
* Prepare and deliver training modules as required.
* Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis.
* Support continuous improvement through Lean Six Sigma methodologies.
* Execution / development of change controls.
* 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 whys etc.; Implement subsequent corrective action through the change management system.
* Participate / lead cross functional teams including liaising with vendors on projects.
Qualifications & Key Attributes:
* Third level qualification in Engineering, Polymer Science, or equivalent.
* Excellent interpersonal, communication, influencing, and facilitation skills.
* A minimum of 2 years experience as a Validation Engineer within an Injection moulding or medical manufacturing environment.
Skills:
* Engineering
* Polymer Science
* Manufacturing
* Minitab
* Injection Molding