Validation Engineer – Injection Moulding | Full-time | 12 months
Roscommon | Healthcare Manufacturing
A leading healthcare manufacturing organisation specialising in high-volume injection moulding and polymer-based medical devices is seeking a Validation Engineer to support new product introductions and ongoing process validation activities.
The Role
The Validation Engineer will be responsible for supporting process validation, equipment qualification, and continuous improvement activities across injection moulding operations within a regulated GMP environment.
You will work closely with cross-functional teams to ensure robust validation of new tools, materials, and processes.
Key Responsibilities
Write and execute process validation protocols and reports (IQ/OQ/PQ) for new product introductions and revalidations
Support change control activities and ensure compliance with validated systems
Generate and review risk assessments (FMEA, process, cleaning, validation)
Execute and review FAT/SAT protocols for equipment and tooling
Support GMP compliance and regulatory audits
Perform data analysis and provide technical recommendations
Lead root cause analysis (5 Whys, Fishbone, etc.) and support CAPA activities
Support continuous improvement using Lean Six Sigma tools
Collaborate with cross-functional teams and external suppliers
Requirements
Third-level qualification in Engineering, Polymer Science, or equivalent
Minimum 2 years’ experience in validation within injection moulding or medical device manufacturing
Strong understanding of IQ/OQ/PQ, GMP, and ISO13485
Experience with statistical analysis tools (e.g., Minitab,SPC)
Strong problem-solving and communication skills
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