Computer System Validation Engineer
We are seeking an experienced Computer System Validation Engineer to join our team in Ireland West Sligo.
About the Role
This is an exciting opportunity for someone who wants to make a real impact and be part of a company's journey from start-up to ramp-up.
Responsibilities
* Manage CSV automation change controls and non-conformances.
* Participate in the review of CSV procedures and protocols.
* Ensure compliance with CSV, Annex 11, and experience with ERP in a GMP manufacturing environment.
Day-to-Day Activities
1. Prepare and review validation documentation related to projects and change controls.
2. Execute validation activities and protocols on affected systems.
3. Manage computer system/automation-related change controls and other compliance-related tasks.
4. Analyze the results of testing and determine the acceptability of results against predetermined criteria.
5. Investigate and troubleshoot problems that occur and determine solutions or recommendations for changes and/or improvements.
6. Audit internal projects against internal validation policies and procedures.
7. Coordinate the review and approval of specifications associated with Computerised Systems.
8. Communicate the company's computer validation policies during regulatory audits.
Requirements
* Third-level degree in Science, Engineering, or Computer Science.
* 3+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation.