Computer System Validation Engineer
We are looking for an experienced Computer System Validation Engineer to join our team in Ireland West – Sligo.
About the Role
This is a permanent position that offers the opportunity to make a real impact and be part of a company's journey.
We are seeking options with circa 3 years experience in CSV, with highly desirable skills including:
* Managing CSV automation change controls and non-conformances
* Participating in reviews of CSV procedures and protocols
* Ensuring compliance for CSV, Annex 11, and GMP manufacturing environments
Day-to-Day Responsibilities
The successful candidate will:
* Prepare and review validation documentation related to projects and change controls, including risk assessments and validation reports
* Execute validation activities and protocols on affected systems
* Manage computer system/automation related change controls and other compliance tasks
* Analyze test results and determine acceptability against predetermined criteria
* Investigate and troubleshoot problems, determining solutions or recommendations for changes and improvements
* Audit internal projects against internal validation policies and procedures
* Coordinate the review and approval of specifications associated with Computerised Systems
* Communicate company computer validation policies during regulatory audits
* Support Quality Approval of Vendors and Suppliers of GxP computer systems
* Assess company computer systems and identify potential 21CFR Part 11 or EU Annex 11 gaps
Requirements
To be considered for this role, you will need:
* A third-level degree in Science, Engineering, or Computer Science
* At least 3 years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation