At a Glance
- Tasks: Ensure GMP systems are validated and ready for inspection while improving reliability and compliance.
- Company: Join a leading biopharmaceutical company committed to innovation and quality.
- Benefits: Enjoy 35 days holiday, competitive pension, and training opportunities in a dynamic environment.
- Other info: Be part of a diverse team dedicated to changing the world through advanced therapies.
- Why this job: Make a real impact on product quality and collaborate with industry experts.
- Qualifications: Honours degree in Engineering or related field with 3+ years in Validation or Compliance.
The predicted salary is between 40000 - 50000 £ per year.
Location: Billingham UK
About the role
We are seeking a Qualification Engineer to ensure GMP manufacturing, QC, and supply chain systems are validated, controlled, and inspection-ready. You will 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 will 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 will 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, TrackWise, 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%+ and we contribute 7% (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.
We are part of the Fujifilm Group, and we all share the same purpose. Giving our world more smiles. We bring diverse ideas, unique capabilities, and extraordinary people together to change the world. FUJIFILM Biotechnologies works in strategic collaboration with biopharmaceutical and biotech companies to develop and manufacture the latest in biologics, advanced therapies and vaccines. With production facilities in the US and Europe, we give our customers everything they need to develop and commercialize treatments and therapies effectively and efficiently to make patients' lives better. We are driven to revolutionize the industry through our Partners for Life mindset, seeking to build global partnerships based on trust with our customers. Our global teams fully embrace our aspiration of being the leading and most trusted Partners for Life in the biopharmaceutical industry.
Qualification Engineer in Billingham employer: FLBK FUJIFILM Diosynth Biotechnologies UK Limited
FLBK FUJIFILM Diosynth Biotechnologies UK Limited is an exceptional employer, offering a dynamic work environment in Billingham where innovation meets compliance. With a strong focus on employee growth and development, you will have the opportunity to lead a talented team while enjoying generous benefits such as 35 days of holiday. Join us to make a meaningful impact in the pharma/biotech industry and thrive in a culture that values collaboration and excellence.
Contact Details:
FLBK FUJIFILM Diosynth Biotechnologies UK Limited Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Qualification Engineer in Billingham
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We think you need these skills to ace Qualification Engineer in Billingham
Some tips for your application 🫡
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Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that FLBK FUJIFILM Diosynth Biotechnologies UK Limited does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
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How to prepare for a job interview at FLBK FUJIFILM Diosynth Biotechnologies UK Limited
✨Brush Up on Lab Techniques
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Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
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