At a Glance
- Tasks: Lead validation projects and ensure compliance for GMP manufacturing.
- Company: Join a leading biopharma company committed to quality and innovation.
- Benefits: Enjoy 35 days holiday, competitive salary, and a generous pension plan.
- Other info: Work with advanced technologies in a dynamic and regulated environment.
- Why this job: Make a real impact by safeguarding medicines for patients worldwide.
- Qualifications: 5+ years in GMP validation with strong data analysis skills.
The predicted salary is between 50000 - 65000 £ 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.
Responsibilities
- 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.
Qualifications
- 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.
Benefits
- 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.
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: FLBK FUJIFILM Diosynth Biotechnologies UK Limited
Fujifilm is an exceptional employer, offering a dynamic work environment in Billingham where innovation meets compliance in the biopharma sector. With a commitment to employee growth through coaching and advanced training, alongside competitive benefits such as 35 days of holiday and a robust pension plan, we ensure that our team members thrive while contributing to the vital mission of safeguarding medicines for patients worldwide.
Contact Details:
FLBK FUJIFILM Diosynth Biotechnologies UK Limited Recruitment Team
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 don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can land you that Senior Qualification Engineer role.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and understanding of GMP regulations. We recommend practising common interview questions and even doing mock interviews with friends or mentors. Confidence is key, so let your expertise shine!
✨Tip Number 3
Showcase your problem-solving skills! Be ready to discuss specific examples where you’ve tackled complex issues in validation or compliance. We want to see how you approach challenges and drive effective root cause analysis – it’s what sets you apart from the crowd.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged. So, get your CV polished and hit that apply button!
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.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share your passion for ensuring compliance and quality in manufacturing, and don’t forget to mention any relevant achievements that demonstrate your expertise.
Showcase Your Technical Skills:We want to see your technical prowess! Be sure to include details about your experience with validation testing equipment and your familiarity with BS/EN/ISO standards. This will help us understand your qualifications better.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at FLBK FUJIFILM Diosynth Biotechnologies UK Limited
✨Know Your Validation Strategies
Make sure you brush up on risk-based validation and qualification activities. Be ready to discuss how you've led validation projects in the past, especially in GMP environments. Highlight your experience with stage-gated strategies and be prepared to share specific examples.
✨Master the Documentation
Familiarise yourself with the types of validation documentation you'll be expected to prepare and review, like Validation Plans and URS. Bring examples of your previous work to the interview, as this will demonstrate your hands-on experience and attention to detail.
✨Showcase Your Technical Expertise
As a Senior Qualification Engineer, you'll need to act as a subject matter expert. Be ready to discuss complex issues you've encountered and how you approached troubleshooting and root cause analysis. This is your chance to shine, so don’t hold back!
✨Emphasise Team Coaching Skills
Since coaching teams on validation policies is part of the role, think about times you've mentored others or led training sessions. Share how you keep up with regulatory trends and best practices, as this shows your commitment to continuous improvement and team development.
