Computer System Validation Engineer with 3+ years experience within Medical Devices or related Healthcare industry required for permanent role in Galway.

 

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.

 

Requirements: 

  • Degree in Software Engineering or Science/Engineering
  • 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 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.
  • Ability to provide subject matter expertise during inspections and regulatory audits.

  

Please contact Emer Moore in confidence

+35357863188

emoore@emtechrecruitment.ie

Refer a Friend