Computer System Validation Engineer Location: Ireland West – Sligo
Type: Permanent
Did you ever wish you joined a company at the start, when things were going from start-up to ramp-up?
This is the perfect role for you to consider if you are looking to make a real impact and for you to be proud of being part of this great company's journey.
I am looking to speak with candidates that have circa 3 years experience in CSV and the following would be highly desirable:
Managing CSV automation change controls and non-conformances. Be part of a review of CSV procedures and protocols. Ensure compliance for CSV. Annex 11 experience. Experience with ERP in a GMP manufacturing environment. Day to Day Responsibilities: Prepares/reviews validation documentation related to projects/change controls including risk assessments, traceability matrices, and validation reports. Executes validation activities and protocols on affected systems. Manages computer system/automation related change controls and other compliance-related tasks e.g.
non-conformances. Participates in the creation and review of existing and new CSV procedures and policies. Analyses the results of testing and determines the acceptability of results against predetermined criteria. Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. Auditing of internal projects against internal validation policies and procedures. Managing and coordinating the review and approval of specifications associated with Computerised Systems. Coordinates with internal Global Departments or outside contractors/vendors to complete validation tasks. Reviews and approves vendor validation documentation. Participates in regulatory audits and communicates the company's computer validation policies. Supports the Quality Approval of Vendors and Suppliers of GxP computer systems. Assesses the company's computer systems and identifies/addresses any potential 21CFR Part 11 or EU Annex 11 gaps. Manages projects and prepares status reports using Microsoft Project and other communication tools. Supports local IT and Global IT on maintenance and testing of physical network infrastructure and security. Qualifications, Experience and Skills: Requires a third-level degree in Science, Engineering or Computer Science with 3+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; relevant experience may substitute for education.
Reach out to ****** for a friendly chat today.
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