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Equipment Validation Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 19194

Our client a major multinational here in Galway are looking to hire an Equipment Validation Engineer.


The Role:

As the Validation Engineer, you will participate in exciting and varied projects, acting as a technical SME for validation activities. You will manage aspects of equipment, and computerized system validation for any software system used to manufacture medical devices. 


Responsibilities:  

  • 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 organizational 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.

Requirements:

  • 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.

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717