Validation Engineer

3 weeks ago

Longford, Ireland Real Full time

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 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 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 why's 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 Manufacturing experience.


• Experience in statistical analysis (Minitab) / SPC / validations.


• 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

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