Validation Engineer

Our client, a privately owned Irish company based in Longford, is seeking to recruit a Validation Engineer. This person will be responsible for supporting all validation activities associated with the successful qualification of new tools and product introductions.

He or She will report to the Validation Engineer Manager and will support the organization to achieve the new product introduction objectives.

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• Write and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific and technical knowledge.
  
• Develop and implement solutions to sustain and improve the QMS.
  
• Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
  
• Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
  
• Generate risk assessments covering cleaning, validation, and process.
  
• Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
  
• Directly support GMP and regulatory audits.
  
• Prepare and deliver training modules as required.
  
• Perform data analysis and make informed decisions/recommendations based on conclusions reached from data analysis.
  
• Support continuous improvement through Lean Six Sigma methodologies.
  
• Execute and develop change controls.
  
• Perform root‑cause analysis of system failures and substandard performance using standard tools and methods (e.g., FMEA, Fishbone diagrams, 5 why’s).
  
• Implement subsequent corrective action through the change‑management system.
  
• Participate with or lead cross‑functional teams, including liaising with vendors on projects.
  

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• Third‑level qualification in Engineering, Polymer Science or equivalent manufacturing experience.
  
• Experience in statistical analysis (Minitab), SPC, or validations.
  
• Excellent interpersonal, communication, influencing, and facilitation skills.
  
• Minimum of 2 years’ experience as a Validation Engineer within an injection moulding or medical manufacturing environment.
  

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• Minimum of 5 years’ experience working with medical devices.
  
• Strong expertise and knowledge of injection moulding. xcfaprz
  
• Proven track record in validation within regulated environments.
  

• Not Applicable

• Full‑time

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• Quality Assurance
  
• Industries: Accounting
  

Location: Longford, County Longford, Ireland