At a Glance
- Tasks: Ensure GMP systems are validated and ready for inspection while improving reliability and performance.
- Company: Join a leading company in regulated manufacturing with a commitment to quality and compliance.
- Benefits: Enjoy 35 days holiday, competitive salary, and a strong pension plan with flexible options.
- Other info: Training opportunities available to enhance your skills in a dynamic environment.
- Why this job: Make a real impact on product quality and collaborate with industry experts.
- Qualifications: Honours degree in Engineering or related field and 3+ years in C&Q or Validation.
The predicted salary is between 40000 - 50000 £ per year.
About the role: We're seeking a Qualification Engineer to ensure GMP manufacturing, QC, and supply chain systems are validated, controlled, and inspection‑ready.
You’ll plan and execute qualification activities across equipment and utilities, project‑manage asset support work, and embed best‑practice operating methods that improve reliability, compliance, and performance.
- What you’ll do
- Plan, schedule, and maintain the qualified status of GMP equipment and utilities across manufacturing assets.
- Deliver inspection readiness through robust qualification, documentation, and lifecycle management.
- Execute improvements to equipment and utility systems using risk‑ and data‑driven insights.
- Lead or support investigations for deviations, QIPs, and CAPAs; author test plans, protocols, and reports.
- Act or deputise as VSP Owner for direct‑impact equipment and utilities.
- Provide system expertise to promote best‑practice operating methods across Manufacturing, QC, and Supply Chain.
- Interface with internal/external SMEs to stay current with regulations and technologies impacting GMP assets.
- What you’ll bring
- Honours degree (or higher) in Engineering, Microbiology, or a related technical field.
- Strong understanding of GMP and validated state for equipment/utilities.
- 3+ years in Commissioning & Qualification (C&Q), Validation, or Compliance, with a track record delivering protocols, test execution, and reports.
• Hands‑on experience with
- Moist Heat Sterilisation, thermal mapping, biological indicators, steam quality testing.
- HVAC, LAF, MSC testing; VHP systems (e. g., Bioquell Qube isolators).
- Controlled temperature chamber mapping.
- Tools and systems: Microsoft Office, SAP, Siemens SCADA/PCS, Track Wise, Kneat, Veeva.
- Why join us
- Make a tangible impact on product quality, compliance, and operational reliability.
- Collaborate with cross‑functional experts and grow your CQV/validation expertise.
- Training and development opportunities aligned to regulated manufacturing environments.
- Competitive salary, with 35 days holiday (not including Public Holidays), competitive pension: you contribute 4–9%+ and we contribute 7–12% (up to 21% total), with flexible investment/retirement options.
We are committed to providing equal opportunities in hiring, promotion, 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, or veteran status.
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Qualification Engineer in Billingham employer: FUJIFILM Biotechnologies
FUJIFILM Biotechnologies is an excellent employer, offering a dynamic work culture that prioritises innovation and collaboration in the heart of Billingham. Employees benefit from competitive salaries, generous holiday allowances, and robust pension contributions, alongside ample opportunities for professional growth and development within a leading-edge engineering environment focused on process safety and reliability.
