Validation Engineer

Job description

Key Job Responsibilities:

  • Generate validation documentation (URS, IQ, OQ, PQ and process characterization studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerized systems
  • Generate collection plans for the qualification and acceptance of incoming components including product sub-assemblies
  • Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team
  • Ensure consistency on validation/qualification approach across systems and projects.  Review and approve changes to equipment, process, utilities, methods and computerized systems to ensure the validation status of equipment is maintained
  • Ensure validation documents are up-to-date (primarily project MVPs and key inputs)
  • Manage the execution of the product/process validation as per the MVP and project plan
  • Work directly with customer validation representatives to define inputs and requirements to the MVP 
  • Ensure all results and data are correct and follow-up on any gaps or discrepancies
  • Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment
  • Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions
  • Maintain validation procedures and templates up to date, focusing on continuous improvement


Job Requirements:

  • Degree in Science/Engineering with 3+ years’ experience in a similar role within the Medical Devices or related Healthcare industry.
  • Strong knowledge of ISO and FDA quality requirements.
  • Good understanding of validation concepts and documentation.
  • Strong communication skills, including ability to advise and influence.
  • Excellent attention to detail and report-writing ability
  • Proven ability to work on own initiative.
  • Highly organized with strong ability to prioritize tasks.
  • A general knowledge and experience of statistical analysis methods is an advantage.


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent