Join us on an exciting journey as a Computer System Validation Engineer in our Ireland West Sligo location. This is a permanent opportunity to make a real impact and be proud of being part of our company's growth.
We're looking for a talented individual with circa 3 years of experience in Computer System Validation (CSV) and the following skills:
* Managing CSV automation change controls and non-conformances
* Participating in the review of CSV procedures and protocols
* Ensuring compliance with Annex 11 and ERP in a GMP manufacturing environment
In this role, you'll be responsible for:
* Preparing and reviewing validation documentation, including risk assessments, traceability matrices, and validation reports
* Executing validation activities and protocols on affected systems
* Managing computer system/automation related change controls and other compliance-related tasks, such as non-conformances
* Participating in the creation and review of existing and new CSV procedures and policies
* Analysing test results and determining their acceptability against predetermined criteria
* Investigating and troubleshooting problems and determining solutions or recommendations for changes and/or improvements
* Auditing internal projects against internal validation policies and procedures
* Coordinating the review and approval of specifications associated with Computerised Systems
* Coordinating with internal Global Departments or outside contractors/vendors to complete validation tasks
* Reviewing and approving vendor validation documentation
* Participating in regulatory audits and communicating our company's computer validation policies
* Supporting the Quality Approval of Vendors and Suppliers of GxP computer systems
* Assessing our company's computer systems and identifying/addressing any potential 21 CFR Part 11 or EU Annex 11 gaps
* 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
To succeed in this role, you'll need:
* A 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; relevant experience will substitute education
If you're passionate about Computer System Validation and want to be part of a dynamic team, please reach out for a friendly chat today.