Validation Engineer
- Galway
- Permanent
- Full-time
This is a fantastic opportunity to join a world leading Medical Device company in Co. Galway, working as a Validation Engineer working 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 executing equipment and process validations with the validation project team. IQ OQ PQ
· 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 validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
carry out and execute process and equipment validations.
Introduction of new equipment to site.
· 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.
· 3+ years' experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.
· Proven track record in validations within manufacturing environment.For more info on this role feel free to get in touch with Gary Keane061-363318 / 086-1030418INDCRG