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 objectivesExperience in authoring, executing and reporting IQ/OQ/PQ and Test Method Validations of Manufacturing Equipment and Processes to meet regulatory requirementsAids 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 exerciseDesignee for Engineering Leader – Validations, as and when requiredOrganize 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 requirementsProvide 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 schedulesMaintain site validation status according to regulatory requirements Identify resource requirements and rate limiting steps within Validation Master Plan complianceSupport the provisions of quality data/reports/charts for the manufacturing groupGenerate relevant required documentation in support of regulatory updates and filings Perform any other duties/tasks/projects as require by managementAssume other responsibilities from time-to-time in order to support plant’s strategic plan and personal career plansResponsible for archiving and storage of all completed and approved validation documents Qualifications & Experience; Degree qualified with validation experience from within a scientific regulated environmentA 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 ValidationsExcellent 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