Validation Engineer
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
Location: Head Office, Selby, North Yorkshire
Department: Research & Development / Quality
Reporting to: Senior Validation Engineer
Full Time | Permanent
- Planning, coordinating and delivering validation activities to support both new and existing medical devices. Your responsibilities will include:
- 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.
Essential:
- 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.
Desirable
- 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.
