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