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Job ID: JOB-12071
Validation Engineer II

Galway location – Contract OR Permanent

Key Job Responsibilities:

• Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised 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 computerised 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:
• Level 8 Degree in Science/Engineering with 2+ 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.
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• For further information on this Validation Engineer role in Galway please contact Anna McGowan on 086 4667369 / anna@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Anna McGowan

JOB-12071

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