Validation Engineer
Galway

Contract
​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
  • 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.