Senior Qualification Engineer

Senior Qualification Engineer

Location:

Billingham, UK

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.

• 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 leadership, troubleshooting complex issues and driving effective root cause analysis and CAPA.
• Coach teams on validation policies, SOPs, regulatory trends and best practice.

• 5+ years’ experience in Commissioning & Qualification, Validation or Compliance within a GMP-regulated environment.
• Proven track record developing test plans, protocols and reports, including within electronic validation systems.
• Strong data analysis skills for C&Q test data and results.
• Proficiency with validation testing equipment (e.g., Ellab, KAYE).
• Deep knowledge of BS/EN/ISO standards relevant to GMP manufacture.

• Competitive salary with 35 days holiday (not including public holidays), annual incentive plan and up to 21% on your pension.
• Your work safeguards medicines reaching patients worldwide.
• Ensure our GMP facilities, utilities, and equipment operate to the highest standards.
• Work with advanced technologies and diverse systems (moist heat sterilisation, isolators/VHP, HVAC/LAF/MSC, electronic validation platforms) in a highly regulated biopharma setting.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, or any other protected characteristic.