Validation Engineer
Galway
Contract
Medical Device
Medical Device
Validation Engineer
Job Summary
Manage all aspects of Equipment & computerised system validation for any software systems used in the manufacture of medical devices.
Key Duties
The Person:
Validation Engineer II:
Job Summary
Manage all aspects of Equipment & computerised system validation for any software systems used in the manufacture of medical devices.
Key Duties
- Prepare software validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
- Prepare software design specifications and associated documentation for equipment and systems.
- Ensure software is controlled and stored as per validation procedure guidelines.
- Work with Quality department to ensure equipment validations are in line with plant validation standards.
- Ensure regulatory compliance with European and US software validation requirements.
- Ensure Computerised system validation procedure(s) is (are) kept up to date and maintained.
- Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment.
- Provides software validation/compliance guidance and training to staff across various functions as required.
- 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.
- Creates and executes IV/OT documents and reports, reviews FS's and provides direction and support on validation plans.
- Actively pursues continuous improvement
- Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements for related projects.
- Generates quotations, concepts and business cases for new and upgrade software systems.
The Person:
Validation Engineer II:
- Level 8 qualification in Science/Engineering or Quality.
- Minimum of 4 years’ experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization.
- Proven track record and performance leading validation teams within manufacturing environment.