JO-2406-537032
Software Validation Engineer required for medical device manufacturing facility in Kilkenny. Unique opportunity to join this greenfield manufacturing site and grow your career with a global leader in its field.
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, work instructions.
- Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.
Qualifications and Experience
- Relevant third level qualification IT/ Engineering/Manufacturing/Science is preferred.
- Working knowledge of software validation in medical devices industry or pharmaceutical validations
- Experience working in a 21CFR820 and/or ISO13485 regulated industry desired.
