Validation Engineer

GBUK; Selby; On-site; GBP 45,000 - 65,000; Full time

Job summary

GBUK is seeking a Validation Engineer to join our Head Office team in Selby, North Yorkshire. You will lead validation activities across the product lifecycle to ensure high standards of quality, safety and regulatory compliance in our medical devices.

The role collaborates across R&D, Quality, Regulatory Affairs and Manufacturing to deliver robust validation studies. We value strong technical knowledge, excellent organisation and communication, and a drive to improve validation processes and

Qualifications

• Experience in validation within a regulated manufacturing environment.
• Knowledge of ISO 13485 and related quality management systems.
• Familiarity with sterilisation validation standards (ISO 11135, ISO 11737, ISO 10993-7).
• Strong documentation and record-keeping abilities.
• Experience coordinating multiple validation projects and stakeholders.

Responsibilities

• Produce, review and approve validation protocols, reports and associated technical documentation.
• Review manufacturing processes and documentation to ensure regulatory compliance.
• Coordinate validation projects and maintain validation schedules.
• Collaborate with suppliers and external laboratories for validation evidence.
• Support risk management, change control activities and investigations into non-conformances.
• Assist with audits and provide training to colleagues.
• Identify improvements to validation processes and product quality.
• Escalate product quality or patient safety concerns when needed.

Skills

Validation experience

ISO 13485 knowledge

Risk management

Regulatory compliance

Documentation

Project coordination

Stakeholder management

MS Office

Education

Engineering, Science or related technical degree

Tools

MS Office

Job description

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.