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Validation Engineer

  • Sector: Engineering
  • Contact Email: kevin.griffin@collinsmcnicholas.ie
  • Job Ref: 23072

A leading Medical device company based in Fermoy, Cork is seeking a talented Validation Engineer to join their team.

Responsibilities.

  • Own and support validation activities in a Medical device-regulated environment.
  • Responsible for all Process Validation Execution in Fermoy.
  • Responsible for all Software Validation Execution in Fermoy.
  • Resolution of Problems encountered during validation.
  • Ensure Consistency in validation/qualification approach across systems and projects.
  • Provide guidance and direction in the preparation and execution of validation activities.
  • Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
  • Maintain Validation system including conducting Periodic Reviews
  • Participate in change control processes for manufacturing processes and facility modifications.

Requirements

  • QQI Level 7 Degree in a Science, Electronics, Mechanical or Industrial Engineering
  • Minimum of 2 years of Quality Assurance / Regulatory affairs experience. 
  • Experience in completing Process Validation as per CDRH Guidance
  • Experience in using Gamp 4 or Gamp 5 Software V and V Techniques 
  • Sound understanding and utilization of Problem Solving Techniques
  • Proficient in the use of MS Word, PowerPoint, and Excel.

Benefits

  • Healthcare
  • Pension plan
  • On-site parking
  • Subsidized Canteen
  • Recognition & Service Awards
  • Maternity pay
  • Wellness Initiatives 
  • EAP Program 
  • A competitive salary
  • Flexitime hours

For a confidential discussion and more information on the role, please contact Kevin Griffin

Kevin Griffin

kevin.griffin@collinsmcnicholas.ie

(021) 2427108