CSV Engineer
Kilkenny
Permanent
CSV Engineer - Kilkenny
In this role you will be responsible for creating and implementing the validation program. Creating and maintaining validation documentation for new and existing systems and processes subject to design control. You will also ensure that validation activities are implemented for systems as per requirements and standards as listed in the current Quality Systems Manual. You might also can travel to vendor locations for training in Europe or the US. Previous experience in implementing software projects from greenfield stage.
Responsibilities
In this role you will be responsible for creating and implementing the validation program. Creating and maintaining validation documentation for new and existing systems and processes subject to design control. You will also ensure that validation activities are implemented for systems as per requirements and standards as listed in the current Quality Systems Manual. You might also can travel to vendor locations for training in Europe or the US. Previous experience in implementing software projects from greenfield stage.
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.
- Relevant third level qualification.IT/ Engineering/Manufacturing/Science is preferred.
- 2-3 years working knowledge of software validation in med devices industry.
- Experience carrying out Cyber security assessments.
- Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
