Job Description
Software Validation Engineer required for a medical device manufacturing facility in Kilkenny. This is a unique opportunity to join a greenfield manufacturing site and grow your career with a global leader in the field.
Responsibilities
* Validate and manage the operation of computerized systems.
* Create and review validation documentation in line with regulatory requirements and company policies.
* Develop Software Compliance assessments, including 21 CFR Part 11 and Data Integrity.
* Maintain quality and compliance of Procedures and work instructions.
* Present status reports, identify trends, potential issues, and suggest improvements.
Qualifications and Experience
* Relevant third-level qualification in IT, Engineering, Manufacturing, or Science is preferred.
* Experience with software validation in the medical devices or pharmaceutical industry.
* Knowledge of 21 CFR and ISO regulations is desirable.
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