Our client is seeking a highly skilled Computer Systems Validation Engineer with a strong background in the Med-device industry.
Job Summary:
The successful candidate will play a crucial role in ensuring the quality and compliance of software products within a regulated environment. This position requires a high level of technical expertise, analytical skills, and effective communication.
Responsibilities:
* Validate and operational manage computerized systems to ensure they meet regulatory requirements.
* Create and review validation documentation in accordance with divisional policies and regulatory standards.
* Develop Software Compliance assessments for 21 CFR Part 11 and Data Integrity.
* Maintain quality and compliance status of associated Procedures and work instructions.
* Present and communicate status, reporting metrics, identifying trends, potential issues, and improvement initiatives.
Requirements:
* 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 21CFR820 and/or ISO13485-regulated industry.
Benefits:
* Family health insurance
* Excellent pension scheme
* Life assurance
* Career Development
* Fantastic new facility
* Growing business with access to many more benefits