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Job Description
Seeking a skilled Computer Systems Validation Engineer with experience in software change management and cybersecurity assessments.
Our client is a global medical device organization.
Key responsibilities include:
- Validation and operational management of computerized systems.
- Creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
- Creation of Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
- Maintenance of quality and compliance status of associated Procedures and work instructions.
- Presentation and communication of status, reporting metrics, identifying trends, potential issues, and improvement initiatives.
Qualifications and experience:
- Relevant third-level qualification in Engineering, Manufacturing, or Science.
- 2-3 years of working knowledge of software validation in the medical devices industry.
- Experience working in a 21 CFR 820 and/or ISO 13485-regulated industry.
Benefits:
- Family health insurance.
- Excellent pension scheme.
- Life assurance.
- Career development opportunities.
- Access to a fantastic new facility and a growing business.
Key skills:
- Validation Engineering.
- Software validation.