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.