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Computer Systems Validation Engineer, Kilkenny
Location: Kilkenny, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: f4b77074dff3
Job Views: 4
Posted: 03.06.2025
Expiry Date: 18.07.2025
Job Description:
Our client is seeking a highly skilled Computer Systems Validation Engineer with a strong background in the Med-device industry. As part of the team, you will play a crucial role in ensuring the quality and compliance of their software products.
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 and work instructions.
* Presenting and communicating status, reporting metrics, identifying trends, potential issues, and improvement initiatives, as applicable.
Qualifications and Experience
* Relevant third-level qualification. Engineering/Manufacturing/Science is preferred.
* 2-3 years of working knowledge of software validation in the medical devices industry.
* Experience working in a 21CFR820 and/or ISO13485-regulated industry. Experience in pharmaceutical validations may also be considered.
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