Job Title: Computer System Validation Engineer
An exciting opportunity has arisen for a talented and experienced Computer System Validation Engineer to join our team in Ireland West – Sligo. As a key member of our organization, you will play a pivotal role in shaping the future of our company.
About the Role:
This permanent position requires a skilled professional with circa 3 years of experience in Computer System Validation (CSV) and related fields. The ideal candidate will have expertise in managing CSV automation change controls and non-conformances, reviewing CSV procedures and protocols, ensuring compliance for CSV, and having Annex 11 experience.
Key Responsibilities:
* Prepare and review validation documentation related to projects/change controls, including risk assessments, traceability matrices, and validation reports.
* Execute validation activities and protocols on affected systems.
* Analyze the results of testing and determine the acceptability of results against predetermined criteria.
* Investigate and troubleshoot problems that occur, and determine solutions or recommendations for changes and/or improvements.
* Audit internal projects against internal validation policies and procedures.
* Manage and coordinate the review and approval of specifications associated with Computerised Systems.
* Coordinate with internal Global Departments or outside contractors/vendors to complete validation tasks.
* Review and approve vendor validation documentation.
* Participate in regulatory audits and communicate the company's computer validation policies.
* Support the Quality Approval of Vendors and Suppliers of GxP computer systems.
* Assess the company's computer systems and identify/addresses any potential 21CFR Part 11 or EU Annex 11 gaps.
* Manage projects and prepare status reports using Microsoft Project and other communication tools.
* Support local IT and Global IT on maintenance and testing of physical network infrastructure and security.
Qualifications, Experience and Skills:
We are seeking a highly motivated individual with a third-level degree in Science, Engineering or Computer Science, accompanied by 3+ years of relevant experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation. Relevant experience may substitute for education.