At a Glance
- Tasks: Lead validation projects and ensure compliance for GMP manufacturing.
- Company: Fujifilm, a leader in biopharma with a commitment to quality.
- Benefits: Competitive salary, 35 days holiday, annual incentives, and pension contributions.
- Other info: Join a cutting-edge environment with advanced technologies and excellent career growth.
- Why this job: Make a real impact by safeguarding medicines for patients worldwide.
- Qualifications: 5+ years in GMP validation, strong data analysis, and technical leadership skills.
The predicted salary is between 50000 - 65000 £ per year.
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.
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, and risk assessments (incl. FMEA).
- Provide SME sign‑off and technical leadership, troubleshoot complex issues and drive 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 Biotechnologies
At Fujifilm in Billingham, we pride ourselves on being an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration. As a Senior Qualification Engineer, you'll not only contribute to the vital mission of ensuring safe medicines reach patients globally but also enjoy competitive benefits such as 35 days of holiday, a robust pension plan, and opportunities for professional growth in a cutting-edge biopharma environment.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Qualification Engineer in Billingham
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We can’t stress enough how personal connections can open doors to opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their products and services, especially in GMP manufacturing. We recommend practising common interview questions and tailoring your answers to highlight your experience in validation and compliance.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work, such as validation plans or risk assessments, to demonstrate your skills. We believe that tangible evidence of your capabilities can really set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we often have exclusive roles listed there that you won’t find anywhere else. Let’s get you that Senior Qualification Engineer position!
We think you need these skills to ace Senior Qualification Engineer in Billingham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Qualification Engineer role. Highlight your experience in GMP environments and any specific projects that showcase your skills in validation and qualification activities.
Showcase Your Expertise:In your cover letter, don’t shy away from showcasing your subject matter expertise. Talk about your experience with risk assessments, validation documentation, and any relevant standards you’re familiar with.
Be Clear and Concise:When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to see your qualifications and achievements at a glance.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s the easiest way for us to track your application and ensure it reaches the right people!
How to prepare for a job interview at FUJIFILM Biotechnologies
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and relevant BS/EN/ISO standards. Being able to discuss these confidently will show that you’re not just familiar with the regulations, but that you can apply them effectively in a real-world setting.
✨Prepare for Technical Questions
Expect to dive deep into your experience with validation projects and risk assessments. Be ready to share specific examples of how you've developed test plans or tackled complex issues. This is your chance to showcase your problem-solving skills and technical expertise.
✨Showcase Your Leadership Skills
As a Senior Qualification Engineer, you'll be expected to lead teams and coach others. Prepare to discuss your leadership style and provide examples of how you've guided teams through validation processes or regulatory changes. Highlighting your ability to mentor others will set you apart.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to validation strategies or how they stay ahead of regulatory trends. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
