Senior Qualification Engineer

Senior Qualification Engineer

Location: Billingham, UK

Overview

We’re looking for an experienced Senior Qualification Engineer to lead and deliver risk-based validation and qualification activities that support GMP manufacturing and the supply chain. You’ll drive validation strategies for new facilities, processes, and equipment, ensure the qualified status of site assets, and act as a subject matter expert across change control, engineering modifications, and EHS.

Responsibilities

• Lead validation projects and define stage-gated validation strategies for new and existing facilities, processes, and equipment.
• Ensure systems and equipment remain appropriately qualified, compliant, and fit for GMP manufacture.
• Prepare, review and approve validation documentation, including Validation Plans, URS, functional/design/configuration documents, SOPs, Risk assessments (incl. FMEA).
• Provide SME sign-off and technical le...