Terumo Aortic
Senior Manufacturing Validation Engineer
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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.
Main Responsibilities
- 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 required 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
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Qualifications & Experience
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- 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
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