Job Title
Validation Specialist
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About the Role
We are seeking an experienced professional to support our validation team in Longford, Ireland.
This role is ideal for a skilled validation engineer with a strong background in quality management.
You will be responsible for ensuring that all processes and systems are validated to meet regulatory requirements and industry standards.
Main Responsibilities
* Develop and execute process validation protocols and reports for new product introductions and revalidations
* Maintain and support compliance to ISO 13485 and ISO 14001 systems standards
* Participate in site change control and ensure effective identification and implementation of changes
* Generate risk assessments and review Factory Acceptance Testing and Site Acceptance Testing protocols
Requirements
* Third level qualification in Engineering or equivalent
* Minimum of 5 years experience working with Medical Devices
* Strong expertise and knowledge of Injection Moulding
* Proven track record in validation within regulated environments
Preferred Skills
* Polymer
* Engineering
* Injection moulding
* Lean six methods
* Minitab