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Junior Software Validation Engineer

4 weeks ago

Kilkenny, Kilkenny, Ireland Cpl Full time

JO--

Software Validation Engineer required for medical device manufacturing facility in Kilkenny. Unique opportunity to join this greenfield manufacturing site and grow your career with a global leader in its field.

Responsibilities

The validation and operational management of computerized systems. The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.  Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity. Maintaining the quality and compliance status of associated Procedures, work instructions. Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.

Qualifications and Experience

Relevant third level qualification IT/ Engineering/Manufacturing/Science is preferred. Working knowledge of software validation in medical devices industry or pharmaceutical validations Experience working in a 21CFR and/or ISO regulated industry desired.