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
6. Relevant third-level qualification. Engineering/Manufacturing/Science is preferred.
7. 2-3 years of working knowledge of software validation in the medical devices industry.
8. Experience working in a 21CFR820 and/or ISO13485-regulated industry. May consider the experience in pharmaceutical validations
Benefits
9. Family health insurance,
10. Excellent pension scheme
11. Life assurance
12. Career Development
13. Fantastic new facility
14. Growing business plus access to many more benefits.