Manufacturing Validation Engineer (Hybrid)

CREGG are now recruiting for Manufacturing Validation Engineer. Hybrid role. 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.

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• 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 & computerised system validation for any software systems used in the manufacture of medical devices.
  

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• 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.
  

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• Level 8 qualification in Science/Engineering or Quality.
  
• 2+ years’ experience in a Manufacturing/ Validation role within medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.
  
• Proven track record in validations within manufacturing environment.
  
• Process / Equipment IQOQPQ execution. xcfaprz
  

For more info on this role feel free to get in touch with Gary Keane [emailprotected] /