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Job Title Location Salary  
Principal QA Validation Specialist Limerick Not Disclosed
QA Validation Manager Limerick Not Disclosed
Computer Systems Validation Engineer Dublin Not Disclosed
Computer Systems Validation Engineer Dublin Not Disclosed

Other Medical Device Jobs

Job Title Location Salary  
Global Head of Manufacturing Dublin Not Disclosed
CQV Engineer Dublin Not Disclosed
Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Administration Support Dublin North Not Disclosed
Quality Systems Specialist Cork Not Disclosed
Senior Engineer Process Development Dublin Not Disclosed
Program Manager, R&D Medical Devices Cork Not Disclosed
Program Manager, R&D Medical Devices Cork Not Disclosed
Senior QA Executive Galway Not Disclosed
Manager/Senior Manager Pharmaceutical Development R&D Waterford Not Disclosed
Commissioning Qualification Validation (CQV) Engineer Cork Not Disclosed
Program Manager, R&D Medical Devices Cork Not Disclosed

Validation Specialist Career Profile

Validation Specialist

Validation is a Quality assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders. A highly technical position, the validation engineer completes or oversees all the calibration and testing of the various instruments and pieces of equipment. Validation is associated with all aspects of medical device industry from laboratories, manufacturing to computer software

Key Responsibilities of the Validation Engineer

  • The execution and completion of process, systems and equipment validations and revalidations in accordance with Validation Master Plans, schedules and Company policy.
  • Co-ordinate activities in all areas of validation
  • Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
  • As assigned, participate in cross functional teams to establish validation strategies and objectives to support the business
  • As needed, assist in providing related training and support. 
  • Provide guidance and support to all departments/staff as needed regarding related issues, ensuring compliance, as applicable, with ISO13485 and all other Quality Standards, Validation Regulations and Guidance Documents.
  • Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents.  
  • Monitor the progress of validation projects on a daily/weekly basis ensuring that there is continuous drive/focus on meeting schedules.
  • Participate in/Lead the review of validation practices in the company; monitor trends, and initiate improvement opportunities.

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