Validation Engineer

GBUK Group; Selby; On-site; GBP 45,000 - 60,000; Full time

Job summary

GBUK Group is seeking a Validation Engineer to join the R&D/Quality team at the Head Office in Selby, North Yorkshire. You will lead validation activities across the product lifecycle, ensuring regulatory compliance and high-quality medical devices.

You will collaborate with R&D, Quality, Regulatory Affairs and Manufacturing, producing protocols and reports, reviewing processes, and supporting audits. Relevant ISO standards and a strong documentation focus are essential.

Qualifications

• Knowledge of medical device process validation requirements and ISO 13485.
• Understanding of sterilisation validation standards ISO11135, ISO11737 and ISO10993-7.
• Knowledge of cleanroom standards ISO14644.
• Excellent written documentation skills with 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.
• Experience in the medical device industry.
• Around three years' experience in validation within a regulated manufacturing environment.
• Experience in FMCG or another highly regulated manufacturing sector.

Responsibilities

• Plan, coordinate and deliver validation activities for new and existing medical devices.
• Produce, review and approve validation protocols, reports and documentation.
• Review manufacturing processes for compliance with medical device regulations and standards.
• Collaborate with suppliers to obtain validation evidence.
• Support risk management activities and contribute to Risk Management Files.
• Plan validation projects, maintain schedules and hit milestones.
• Coordinate validation studies with external laboratories and partners.
• Support change control and investigations into non-conformances.
• Assist audits and provide training as needed.
• Identify opportunities to improve validation processes and product quality.

Skills

Project management

Stakeholder management

Documentation

Communication

Quality mindset

Education

Engineering or science degree

Tools

Microsoft 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:

As a Validation Engineer, you'll be responsible for 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.

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.