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Software Validation Engineer

Job Title: Software Validation Engineer
Contract Type: Permanent
Location: Galway
REF: 88861
Job Published: 11 months ago

Job Description

Contact: Catriona Coogan
Telephone: 091730022

Software Validation Engineer
Our client, a medical device company in Galway are currently looking to recruit a Software Validation Engineer for their site.

  • The Software Validation Engineer is a member of the validation team in the Quality department of the company. S/he is primarily responsible for documentation and execution of validation activities in accordance with validation plans and procedures. This position is primarily based in our Galway facility.
Job Responsibilities:
  • Includes the generation, development, modification, and routing of Validation Protocols, Final Reports, Standard Operating Procedures, and Change Controls, as they relate to software system or computerised system qualifications.
  • Troubleshoot validation issues associated with validation projects.
  • Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to computerised systems to ensure the validation status of the system is maintained.
  • Ensure validation documents are up-to-date (primarily MVPs).
  • Ensure all results and data are correct and follow-up on any gaps or discrepancies.
  • Liaise with the functional owners to ensure that computerised system validation requirements are maintained from Purchase to Qualification.
  • 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.
  • Mentor personnel with respect to software and computer validation.
  • Any other duties as required.
Key Requirements:
  • Degree in Software Engineering or 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. Knowledge of electronic records requirements/compliance protocols (cGMP, GMP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliance).
  • Experience with IQ, IOQ, OQ, PQ and Validation Summary Reports as they relate to ERP system qualification.
  • Experience in the validation of PLC, SCADA and HMI.
  • Understanding of validation principals and techniques for software and computerized systems as applied in the medical device industry.
  • Good understanding of validation concepts and documentation.
  • Strong communication skills, including ability to advice 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.
  • Ability to provide subject matter expertise during inspections and regulatory audits.

For further information on this Software Validation Engineer role in Galway please contact Catriona Coogan on 091730022 /
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