Software Validation Engineer
Join a global leader in the medical device manufacturing industry and establish yourself as a key player in our greenfield manufacturing site in Kilkenny.
Key Responsibilities:
* The validation and operational management of computerized systems, ensuring seamless integration with our manufacturing processes.
* Development and review of validation documentation in accordance with regulatory requirements and divisional policies to maintain compliance.
* Creation of Software Compliance assessments such as 21 CFR Part 11 and Data Integrity, guaranteeing data accuracy and reliability.
* Maintenance of Procedures and work instructions related to quality and compliance, ensuring their accuracy and relevance.
* Presentation of status updates, metrics, trends, potential issues, and improvement initiatives to stakeholders.
Required Qualifications and Experience:
* A relevant third-level qualification in IT, Engineering, Manufacturing, or Science is preferred.
* Working knowledge of software validation in the medical devices industry or pharmaceutical validations.
* Desirable experience working in a 21 CFR and/or ISO regulated industry.