Validation Engineer - Galway CREGG are now recruiting for Validation Engineer.
This is a fantastic opportunity to join a world leading Medical Device company in Co. Galway, working as a Validation Engineer on the latest projects and state of the art equipment.
This role offers great working flexibility with great career progression opportunities.
The role: *Responsible for the technical leadership and development of a validation project team.
*Responsible for the assignment of validation activities to the validation project team.
*Manage all aspects of Process, Equipment & computerized 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.
*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 upgrade software systems.
*Project management of sustaining projects.
*Manages & mentors contract employees .
Requirements: *Level 8 qualification in Science/Engineering or Quality.
* Minimum of 2 years experience in a Manufacturing Engineering or Validation role within medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.
* Proven track record and performance in validation teams within manufacturing environment.
For more info on this role feel free to get in touch with Gary Keane Skills: IQ OQ PQ Troubleshooting Validation Design DMAIC LEAN Software validation
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