Validation Engineer
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Job Type | Contractor |
Area | Galway, Ireland |
Sector | EngineeringQuality |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | 3085 |
Job Views | 571 |
- Description
- Team Horizon is seeking a Validation Engineer for our Clients medical device manufacturing facility in Co. Galway. In this role you will be responsible for the leadership & development of a Validation project team and manageall aspects of equipment & computerized system validation for any software systems used in the manufacture of medical devices.
Why you should apply:
This is an exciting opportunity to join an established mutinational medical device company, with an opportunity to work on exciting & varied projects
What you will be doing:
Prepare software validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
Creates and executes 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 & Site validation standards.
Ensure regulatory compliance with global 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.Communicates effectively & efficiently with cross-functional teams on project tasks
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 upgarde software systems.
Project management of sustaining projects.
Manages & mentors contract employees .
What you need to apply:
Level 8 qualification in Science/Engineering or Quality.
Minimum of 5 years’ experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.
Proven track record and performance leading validation teams within manufacturing environment. Availability to travel as required.
Ability to support weekend work as required.