Senior Manufacturing Validation Engineer

Terumo Aortic are currently recruiting for a Senior Manufacturing Validation Engineer to join our team. The successful candidate will be responsible for ensuring equipment and processes are validated to the regulated standards.

The main responsibilities are;

• Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives


• Experience in authoring, executing and reporting IQ/OQ/PQ and Test Method Validations of Manufacturing Equipment and Processes to meet regulatory requirements


• Aids other Validation Engineers with correct approach for Validation activities


• Prepares and issues Validation Master Plans and revalidation schedules, summary reports and other required documentation for a validation exercise


• Designee for Engineering Leader – Validations, as and when required


• Organize and execute validation activities in order to provide an effective validation service


• Provide validation expertise to ensure that all operations are carried out in compliance with regulatory and company requirements


• Provide validation support and advice to other areas of the business as and when required


• Provide specialist knowledge on process, equipment issues within the site


• Promote effective working relationships and ensure they are maintained through the validation working party


• Support a continuous improvement culture within the business


• Address site validation gaps via generation and completion of Validation Master Plans and schedules


• Maintain site validation status according to regulatory requirements


• Identify resource requirements and rate limiting steps within Validation Master Plan compliance


• Support the provisions of quality data/reports/charts for the manufacturing group


• Generate relevant required documentation in support of regulatory updates and filings


• Perform any other duties/tasks/projects as require by management


• Assume other responsibilities from time\-to\-time in order to support plant’s strategic plan and personal career plans


• Responsible for archiving and storage of all completed and approved validation documents

• Degree qualified with validation experience from within a scientific regulated environment


• A good working knowledge of appropriate standards and regulations


• Experience in direct investigation/troubleshooting of validation problems


• Experience in authoring, executing and reporting IQ/OQ/PQ and Test Method Validations


• Excellent statistical knowledge (DOE, capability studies, Gauge R\&R, sample size definition, etc)


• Experience in the areas of qualification, analytical methods, lab equipment qualification, computer system validation, and re\-qualification

This listing is from Indeed. View original listing ↗