Validation Engineer

CREGG Recruitment are currently hiring a Quality Validation Engineer for a large medical company in Galway. For more information call Stephen Coen 0861030418 Email stephencoen@cregg.ie

 About the Job

As our newest member of the Validation Engineering team, you will participate in exciting and varied projects, acting as a technical SME for validation activities.  In your new role, you will manage aspects of equipment, and computerised system validation for any software system used to manufacture medical devices.

So if you are interested in a rewarding career as a Validation Engineer and ready to join a team focused on innovation and delivering a first class service, read on for more information and start the application today.

 

Key Activities of the Role:

 

  • Prepare software validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
  • Review Equipment Function specs and provides direction and support on validation strategy and plans.
  • Work with the 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) are kept up to date and maintained.
  • Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment.
  • Provide software validation/compliance guidance and training to staff across various functions as required.
  • Develop and enhances cross-functional team relationships and work cross-functionally to identify and resolve technical and organisational issues.
  • Ensure the Equipment Engineering Group employs best validation practices to maximise effectiveness and minimise non-value-added work.
  • Communicate 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 the team can meet delivery requirements for related projects.
  • Generate quotations, concepts and business cases for new and upgraded software systems.
  • Take part in or lead sustaining projects to support business goals and objectives.

 

Qualifications and Experience:

 

  • NFQ Level 8 qualification in a STEM discipline.
  • Minimum of 3-5 years experience in a Validation role within a medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.
  • Proven track record and performance executing validation activity independently or as part of a team in multiple areas.
  • Availability to travel as required
  • Ability to support weekend work as required
+ Apply

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