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Computer Systems Validation Engineer, Kilkenny
Client:
Location: Kilkenny, Ireland
Job Category:
Other
EU work permit required: Yes
Job Reference:
f4b77074dff3
Job Views:
86
Posted:
21.01.2025
Expiry Date:
07.03.2025
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:
1. The validation and operational management of computerized systems.
2. The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
3. Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
4. Maintaining the quality and compliance status of associated Procedures and work instructions.
5. Presenting and communicating status, reporting metrics, identifying trends, potential issues, and improvement initiatives, as applicable.
Qualifications and Experience:
1. Relevant third-level qualification. Engineering/Manufacturing/Science is preferred.
2. 2-3 years of working knowledge of software validation in the medical devices industry.
3. Experience working in a 21CFR820 and/or ISO13485-regulated industry. May consider the experience in pharmaceutical validations.
Benefits:
* Family health insurance
* Life assurance
* Fantastic new facility
* Growing business plus access to many more benefits
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