I'm seeking an experienced Validation Engineer to join an expanding medical device company here in Galway. This job is open due to new projects and expansion so it's a brilliant time to join the company.
You will manage all aspects of Equipment & Computerised system validation for any software systems used in the manufacture of medical devices.
The hiring manager told me that you will be join a great team and culture so personality fit is very important for this job too!
- Prepare software validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
- Create and execute protocols and reports, reviews Equipment Function Spec's and provides direction and support on validation strategy and plans.
- Work with Quality department to ensure equipment validations are in line with global and site validation standards.
- Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment.
- Develops and enhances cross-functional team relationships and works cross-functionally to identify and resolve technical and organisational issues.
- Ensure best validation practices are employed by the Equipment Engineering Group so as to maximise effectiveness and minimise non-value added work.
- Communicates effectively & Efficiently with cross-functional teams on project tasks
- Ensure regulatory compliance with global software validation requirements.
- Project management of sustaining projects
- Actively pursues continuous improvement
- Generates quotations for new and upgarde software systems.
- Level 8 qualification in Science/Engineering or Quality.
- Minimum of 3 years’ experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization.
- Proven track record and performance executing validation activity independently or as part of a team in multiple areas.
- Availability to travel as required.
- Ability to support weekend work as required
For more information, please contact Emma on 091 455 307.
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