Job Description
A highly skilled Computer Systems Validation Engineer is sought after with a strong background in the Med-device industry. This individual will play a crucial role in ensuring the quality and compliance of software products.
Responsibilities
* The validation and operational management of computerized systems.
* The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
* Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
* Maintaining the quality and compliance status of associated Procedures, and work instructions.
* Presenting and communicating status, reporting metrics, identifying trends potential issues, and improvement initiatives, as applicable.
Qualifications and Experience
* Relevant third-level qualification. Engineering/Manufacturing/Science is preferred.
* 2-3 years of working knowledge of software validation in the medical devices industry.
* Experience working in a 21CFR820 and/or ISO13485-regulated industry. May consider experience in pharmaceutical validations.