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Validation Engineer

Opportunity for an experience Validation Engineer to join growing medical device company based in Sligo.

Avenue - a Nolato company based in Finisklin Business Park, Sligo is an award-winning mould-building company, and a growing medical device precision injection moulding business that has been successfully serving Ireland and the broader European markets for 30 years. Avenue also brings expertise in building ultra-high-cavitation tooling for the medical device, diagnostics, and pharmaceutical markets.


The QA Validation Engineer will support the Validation, Quality, and Metrology departments.


  • Generation, maintenance, execution and completion of process, systems, moulding machines, and equipment validation and/or revalidation in accordance with Project Validation plans, schedules and Company policy.
  • Coordinate with the Operations, Engineering, NPI & Project teams to ensure validation and/or revalidation activities are appropriately planned to coincide with the overall implementation timelines.
  • Prepare, execute, and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
  • Be an integral role in decision making relating to validation and/or revalidation activities at the site.
  • Ensure consistency on validation/qualification approach across processes, systems, and projects with adherence to company validation procedures.
  • As needed, liaise directly with customers regarding queries and issues.
  • Provide validation expertise and guidance on overall validation strategy for all activities requiring validation on site, ensuring compliance, as applicable, with ISO13485 and all other Quality Standards and Validation documents.
  • Support process validation quality activities as part of an overall Project, Engineering & NPI teams.
  • Manage the execution of approved validation protocols, requiring product sampling and strong communication skills.
  • Draft and review validation protocols and reports in line with internal and regulatory requirements.
  • Review and approve validation documentation for systems, equipment and manufacturing processes.
  • Prepare quality related documentation for NPI projects through validation stages e.g., Standard Operating Procedures, work instructions, test methods and Batch records.
  • Review and approve changes to equipment, process, utilities, methods, and systems to ensure the validation status of equipment is maintained.
  • Troubleshoot/investigating validation related deviations
  • Carry out statistical analysis of data and generate reports as required.
  • Training and communication of validation protocols and activities to the relevant departments.
  • Any other duties to support the Quality and Validation function as directed by the Quality and Regulatory Affairs Manager.


  • Degree in Quality and/or Engineering or a relevant technical discipline essential.
  • 3 years relevant Validations experience in the medical device/ manufacturing industry.
  • Computer Software Validation experience is desired.
  • Excellent attention to detail, problem solving and strong communication skills.
  • Computer proficient in MS Word and Excel. Previous experience with Minitab is preferable.
  • Proven Self-Starter with previous experience working on own initiative.


Sligo, Ireland

Apply by

October 05, 2023

Contact person

Sonya Connolly [email protected]