At a Glance
- Tasks: Lead validation projects and ensure compliance for GMP manufacturing.
- Company: Join a leading biopharma company dedicated to patient safety.
- Benefits: Competitive salary, 35 days holiday, annual incentives, and pension contributions.
- Other info: Work with cutting-edge technologies in a dynamic and supportive team.
- Why this job: Make a real impact by safeguarding medicines for patients worldwide.
- Qualifications: 5+ years in validation or compliance within a GMP environment.
The predicted salary is between 50000 - 55200 £ per year.
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.
What you’ll do
- 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.
What you’ll bring (essential)
- 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.
Why join FDB Billingham
- Purpose and impact: Your work safeguards medicines reaching patients worldwide. You’ll help ensure our GMP facilities, utilities, and equipment operate to the highest standards.
- Cutting-edge environment: Work with advanced technologies and diverse systems (e.g., moist heat sterilisation, isolators/VHP, HVAC/LAF/MSC, electronic validation platforms) in a highly regulated biopharma setting.
- Competitive salary, with 35 days holiday (Not including Public Holidays), annual incentive plan and up to 21% on your pension.
Equal opportunity 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.
Senior Qualification Engineer in Billingham employer: Fujifilm
Fujifilm is an exceptional employer, offering a dynamic work environment in Billingham where your contributions directly impact global health by ensuring the highest standards in GMP manufacturing. With a commitment to employee growth, competitive salaries, and generous benefits including 35 days of holiday and a robust pension plan, you will thrive in a culture that values innovation and diversity while working with cutting-edge technologies in the biopharma sector.
