Highly skilled Computer Systems Validation Engineer sought for the Med-device industry.
Responsibilities
* Validate and manage computerized systems to ensure quality and compliance.
* Create and review validation documentation according to regulatory requirements and divisional policies.
* Develop Software Compliance assessments, including 21 CFR Part 11 and Data Integrity.
* Maintain Procedures, work instructions, and associated documents to ensure quality and compliance.
* Present and communicate status, metrics, trends, potential issues, and improvement initiatives.
Qualifications and Experience
* Relevant third-level qualification in Engineering/Manufacturing/Science preferred.
* 2-3 years of working knowledge in software validation within the medical devices industry.
* Experience in a 21CFR820 and/or ISO13485-regulated industry; pharmaceutical validations may also be considered.
Benefits
* Family health insurance
* Excellent pension scheme
* Life assurance
* Career development opportunities
* Access to a new facility and growing business environment