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Validation Engineer
Sterigenics
England, GBR
Full Time, Contract
Mid
Onsite
Discovered 1 weeks ago
FDAISOIQOQPQ
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Role Overview
Reporting to the Quality Assurance Manager, the Validation Engineer serves as the facility's technical representative for validation activities, ensuring compliance with ISO standards, FDA regulations and customer requirements. You will work across multiple functions including Operations, Engineering, Sales, Quality and external customers to successfully plan, execute and document validation programmes.
Key Skills for This Role
FDAISOIQOQPQ
Full Job Posting
About the Role
Reporting to the Quality Assurance Manager, the Validation Engineer serves as the facility's technical representative for validation activities, ensuring compliance with ISO standards, FDA regulations and customer requirements. You will work across multiple functions including Operations, Engineering, Sales, Quality and external customers to successfully plan, execute and document validation programmes.
Key Responsibilities
- Plan, coordinate and manage customer validation projects from initiation through to completion.
- Write validation protocols, reports and supporting technical documentation.
- Review customer-supplied validation protocols to ensure compliance and operational feasibility.
- Execute validation studies, including scheduling processing runs, laboratory testing and sample management activities.
- Collect, analyse and interpret validation data.
- Support equipment qualification activities, including IQ, OQ and PQ protocols.
- Ensure calibration activities are performed in accordance with the Sterigenics Quality Management System and relevant standards.
- Maintain accurate and compliant validation records and documentation.
- Lead improvement projects to enhance efficiency and reduce process deficiencies.
- Act as a technical contact for customers and internal stakeholders on validation-related matters.
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