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 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. 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
