Senior Manufacturing Validation Engineer - IQ/OQ/PQ Lead

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 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.