Location: Head Office, Selby
Reports to: Senior Validation Engineer
GBUK Group is a leading designer and manufacturer of innovative medical devices supplied to healthcare providers worldwide. As we continue to grow and expand our product portfolio, we are looking for a Validation Engineer to join our team at our Head Office near Selby.
This is an excellent opportunity for an individual with experience in validation, quality systems, or medical device manufacturing who is looking to develop their career within a dynamic and highly regulated industry.
Your own vehicle and full drivers licence is required for this role as theer are no public transport links to our site.
The Role
As a Validation Engineer, you will play a key role in ensuring GBUK products meet applicable regulatory, quality, and customer requirements. Working closely with internal departments, suppliers, laboratories, and customers, you will support validation activities across new product development, product maintenance, and continuous improvement projects.
You will help ensure manufacturing processes, sterilisation activities, and associated documentation comply with relevant international standards and regulatory requirements.
Key Responsibilities
- Communicate with suppliers to ensure manufacturing and validation documentation meets regulatory requirements.
- Generate, review, and maintain validation protocols, reports, and associated documentation.
- Review manufacturing documentation against applicable international standards and guidance.
- Contribute to Risk Management Files for new and existing products, including process risk assessments.
- Coordinate validation projects and maintain validation schedules and project plans.
- Liaise with external partners, laboratories, and customers to deliver validation studies on time.
- Complete assigned actions arising from change control activities.
- Support Quality Assurance with root cause investigations, NCRs, and customer complaints.
- Escalate product quality and safety concerns where appropriate.
- Support internal and external audits.
- Deliver training on relevant validation and compliance activities.
- Identify opportunities for process improvements and support continuous improvement initiatives.
About You
Essential
- Knowledge of process validation requirements within Medical Device Regulations and ISO 13485.
- Knowledge of sterilisation standards including ISO 11135, ISO 11737, and ISO 10993-7.
- Understanding of cleanroom standards, including ISO 14644.
- Strong organisational and communication skills.
- Competent user of Microsoft Office applications.
- Full UK driving licence and access to a vehicle.
- A proactive, solution-focused approach with excellent attention to detail.
Desirable
- Degree in a Science, Engineering, or Medical-related discipline.
- Experience within a manufacturing or FMCG environment.
- Previous validation experience within the medical device industry (ideally 3+ years).
What We're Looking For
We are seeking someone who demonstrates our core values:
- Integrity
- Teamwork & Collaboration
- Innovation
- Adaptability
- Continuous Improvement
- Solution-Focused Thinking
Why Join GBUK?
At GBUK, you'll be joining a collaborative and purpose-driven organisation dedicated to improving patient outcomes through innovative medical technology. We offer the opportunity to work on meaningful projects, develop your technical expertise, and contribute to products used globally within healthcare settings.
If this sounds like the next step in your career, we'd love to hear from you.
GBUK Group is committed to creating an inclusive workplace where diversity is valued and everyone is given the opportunity to succeed. We welcome applications from all suitably qualified candidates regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, or sexual orientation.
Pay: £35,000.00-£40,000.00 per year
Benefits:
- Additional leave
- Company events
- Company pension
- Cycle to work scheme
- Employee discount
- Enhanced maternity leave
- Enhanced paternity leave
- Free flu jabs
- Free parking
- Health & wellbeing programme
- On-site parking
- Referral programme
- Sick pay
Licence/Certification:
- Driving Licence (required)
Work authorisation:
- United Kingdom (required)
Work Location: In person
