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Search Results for Validation Specialist
Job Title. Location Salary Actions

Senior Validation Specialist Cold Chain

Senior Validation Specialist Cold Chain Our client, a leading biotech organisation are currently recruiting for a Senior Cold Chain Validation Specialist to join their team on a permanent basis. As Senior Cold Chain Validation Specialist you will supervise a team of validation specialists in cold chain management who are responsible for the review and approval of Initial and Continuing validation and qualification documentation for QA Validation. You will also be responsible for ensuring that systems and processes are qualified and/or validated in accordance with regulatory requiremen...

Location: Limerick,
Senior Validation Specialist Cold Chain
Limerick Not Disclosed

System Development Engineer

Systems Development Engineer Job Description Summary Our client, a market leading medical device company is looking for a highly talented Senior Systems Engineer to take responsibility for providing their systems knowledge to the company for further development efforts for their Diabetes Care business unit segment focusing on infusion pumps. The Systems Development Engineer will need to demonstrate a good understanding of fundamental/traditional systems engineering principles, procedures and techniques across the spectrum to connect various functional elements related to the develop...

Location: Dublin,
System Development Engineer
Dublin Not Disclosed

QA Validation Manager

QA Validation Manager Our client, a large biopharmaceutical organisation are currently recruiting for a QA Validation Manager to join their team on a permanent basis. As QA Validation Manager you will be responsible for implementing policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and the organisations manufacturing standards, and will manager a team of Validation Specialists. Responsibilities • Manage, develop and build a team of subject matter experts in the areas of cleaning validation and...

Location: Limerick,
QA Validation Manager
Limerick Not Disclosed
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Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Industrial Engineer Dublin Not Disclosed
Senior Quality Engineer Limerick Not Disclosed
Senior Process Development Engineer Dublin Not Disclosed
Senior Manager Device and Product Performance Dublin Not Disclosed
Equipment Engineer Dublin Not Disclosed
Associate Director Quality Risk Management System Limerick Not Disclosed
Senior Manager Device and Product Performance Dublin Not Disclosed
Validation Engineer Dublin 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.