Computer System Validation Engineer Ireland West Sligo Permanent
This is an ideal role for those looking to make a real impact and be proud of being part of a company's journey. We are seeking options with circa 3 years experience in CSV.
Desirable skills include:
* Managing CSV automation change controls and non-conformances
* Participating in the review of CSV procedures and protocols
* Ensuring compliance for CSV Annex 11
* Experience with ERP in a GMP manufacturing environment
Day-to-Day Responsibilities:
* Preparing and reviewing validation documentation, including risk assessments and validation reports
* Executing validation activities and protocols on affected systems
* Managing computer system/automation related change controls and other compliance tasks
* Participating in the creation and review of CSV procedures and policies
* Analyzing test results and determining acceptability against predetermined criteria
* Troubleshooting problems and determining solutions or recommendations for changes and improvements
* Auditing internal projects against validation policies and procedures
* Coordinating the review and approval of specifications associated with Computerised Systems
* Communicating with internal departments and external contractors/vendors to complete validation tasks
* Reviewing and approving vendor validation documentation
* Participating in regulatory audits and communicating company computer validation policies
* Supporting Quality Approval of Vendors and Suppliers of GxP computer systems
* Assessing company computer systems and identifying potential gaps under 21CFR Part 11 or EU Annex 11
* Managing projects and preparing status reports using Microsoft project and other communication tools
* Supporting local IT and Global IT on maintenance and testing of physical network infrastructure and security
Requirements:
* Third-level degree in Science, Engineering, or Computer Science
* 3+ years of related experience in Automation, Computer Systems, and IT Infrastructure Qualification/validation