Validation Engineer - Medical Devices (Hybrid UK)

GBUK; Selby; Hybrid; GBP 42,000 - 62,000; Full time

Job summary

GBUK is seeking a Validation Engineer to join its R&D and Quality teams in a hybrid role with the head office in Selby, North Yorkshire. You will lead validation activities across the product lifecycle, ensuring safety, quality and regulatory compliance for medical devices.

You will plan and execute validation studies, review protocols, collaborate with suppliers and laboratories, and contribute to risk management and continuous improvement.

Qualifications

• Knowledge of medical device process validation requirements and ISO 13485.
• Experience with sterilisation validation standards (ISO 11135/ISO 11737/ISO 10993-7).
• Strong documentation and record-keeping skills.

Responsibilities

• Plan, coordinate and deliver validation activities for new and existing devices.
• Produce, review and approve validation protocols and reports.
• Review manufacturing processes for regulatory compliance and standards.
• Coordinate with suppliers for validation evidence and risk management activities.
• Support audits, change control and investigations into non-conformances.

Skills

Validation knowledge

Documentation skills

Project management

Communication skills

MS Office proficiency

Driving licence

Education

Engineering/Science degree

Tools

MS Office

Job description

GBUK is seeking a Validation Engineer to join its R&D and Quality teams in a hybrid role with the head office in Selby, North Yorkshire. You will lead validation activities across the product lifecycle, ensuring safety, quality and regulatory compliance for medical devices.

You will plan and execute validation studies, review protocols, collaborate with suppliers and laboratories, and contribute to risk management and continuous improvement.