Senior Manufacturing Validation Engineer

Terumo Aortic; Inchinnan; On-site; GBP 60,000 - 90,000; Full time

Job summary

Terumo Aortic is seeking a Senior Manufacturing Validation Engineer to ensure equipment and processes are validated to regulated standards. You will plan validation activities, author and report IQ/OQ/PQ validations, and develop Validation Master Plans to maintain regulatory compliance.

Role involves liaising with engineering leaders, coordinating validation efforts, and supporting continuous improvement while archiving all validation documentation.

Qualifications

• Degree qualified with validation experience in a regulated environment.
• Knowledge of standards and regulations.
• Experience in investigating and troubleshooting validation problems.
• Experience in IQ/OQ/PQ and test method validations.
• Strong statistical knowledge (DOE, capability studies, Gauge R&R, sample size).

Responsibilities

• Plan validation activities aligned with project plans and objectives.
• Author, execute and report IQ/OQ/PQ validations of equipment and processes.
• Prepare Validation Master Plans, revalidation schedules and reports.
• Provide validation expertise ensuring regulatory compliance across operations.
• Archive and store all completed validation documents.

Skills

Validation experience

Regulatory knowledge

Statistical methods

Investigation/troubleshooting

Documentation writing

Education

Degree in science/engineering

Job description

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

Qualifications & Experience;

• 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