At a Glance
- Tasks: Lead validation activities for innovative medical devices, ensuring quality and compliance.
- Company: GBUK, a pioneering company in medical device development.
- Benefits: Collaborative culture, professional growth, and the chance to make a real impact.
- Other info: Opportunity to work with experienced specialists and enhance your skills.
- Why this job: Join a team dedicated to improving patient care with cutting-edge technology.
- Qualifications: Degree in Engineering or Science, with validation experience in regulated environments.
The predicted salary is between 35000 - 45000 £ per year.
Location
Head Office, Selby, North Yorkshire
Department
Research & Development / Quality
Reporting to
Senior Validation Engineer
Join GBUK and help deliver medical devices that make a difference.
At GBUK, we develop and manufacture innovative medical devices that improve patient care across the UK and around the world.
As our product portfolio continues to grow, we're looking for a Validation Engineer to join our R&D team and play a key role in ensuring our products meet the highest standards of quality, safety and regulatory compliance.
Working closely with colleagues across R&D, Quality, Regulatory Affairs and Manufacturing, you'll lead and support validation activities throughout the product lifecycle, from exciting new product developments through to continuous improvement of our existing portfolio.
This is an excellent opportunity for someone with validation experience within a regulated manufacturing environment who enjoys solving technical challenges and working collaboratively to bring safe, compliant products to market.
What you'll be doing
- Producing, reviewing and approving validation protocols, reports and associated technical documentation.
- Reviewing manufacturing processes and documentation to ensure compliance with applicable medical device regulations and international standards.
- Working with suppliers to obtain and assess manufacturing and validation evidence.
- Supporting risk management activities, including contributing to Risk Management Files and process risk assessments.
- Planning and coordinating validation projects, maintaining validation schedules and ensuring key milestones are achieved.
- Collaborating with external laboratories, manufacturers and business partners to deliver validation studies on time.
- Supporting change control activities and ensuring validation requirements are completed effectively.
- Assisting with investigations into non-conformances, complaints and root cause analysis.
- Supporting internal and external audits.
- Providing guidance and training to colleagues where required.
- Identifying opportunities to improve validation processes and overall product quality.
- Escalating product quality or patient safety concerns where appropriate.
About you
We're looking for someone who combines strong technical knowledge with excellent organisational and communication skills.
- Knowledge of medical device process validation requirements and ISO 13485 Quality Management Systems.
- Understanding of sterilisation validation standards, including ISO 11135, ISO 11737 and ISO 10993-7.
- Knowledge of cleanroom standards, including ISO 14644.
- Excellent written documentation skills with strong attention to detail.
- Ability to manage multiple projects and priorities.
- Strong communication and stakeholder management skills.
- Proficient in Microsoft Office applications.
- Full UK driving licence and access to a vehicle.
- Degree in Engineering, Science or a related technical discipline.
- Experience within the medical device industry.
- Around three years' experience in validation within a regulated manufacturing environment.
- Experience of working within FMCG or another highly regulated manufacturing sector.
At GBUK, our products support healthcare professionals and improve outcomes for patients across the globe.
We're proud of our collaborative culture, our commitment to innovation and the opportunity we give our people to make a genuine impact.
You'll work alongside experienced technical specialists in an organisation that values continuous improvement, professional development and teamwork.
Our values underpin everything we do
- Integrity
- Solutions Focused
If you're looking for a role where your expertise directly contributes to delivering safe, high-quality medical devices, we'd love to hear from you.
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Validation Engineer in Selby employer: GBUK
At GBUK in North Duffield, Selby, we pride ourselves on being an excellent employer that values collaboration and leadership. Our supportive work culture fosters employee growth through continuous training and development opportunities, ensuring that your contributions are recognised and impactful. Join us to be part of a dynamic team where your leadership can truly make a difference in our operations.
