Validation Engineer - Medical Devices

Job Title: Validation Engineer

Type of company: Medical Device Company

Package: Competitive Salary DoE, Bonus Scheme, Health Cover, Pension, 25 days holiday + BH North Yorkshire | Hybrid working – 2-3 days onsite per week

Everything you need to know about the role:

A growing medical device company is looking for a Validation Engineer with practical experience of manufacturing equipment and process validation. Working closely with Quality, R&D, suppliers and external partners, you will help ensure products and manufacturing processes continue to meet international quality and regulatory requirements while supporting new product development, ongoing

product maintenance and continuous improvement.

This is a varied role offering hands-on involvement across the validation lifecycle, including IQ, OQ and PQ, alongside risk management, change control, audits and supplier collaboration within an ISO 13485-regulated environment.

You will:

• Support manufacturing equipment and process validation activities across the full lifecycle, including IQ, OQ and PQ.

• Generate and review validation protocols, test documentation and reports, as well as manufacturing and supplier documentation, to confirm regulatory and validation requirements are met.

• Contribute to risk management files for new and existing products, including process risk assessments.

• Coordinate validation activities, maintain project plans and keep the company validation schedule up to date.

• Work with suppliers, customers and external laboratories to plan and deliver studies on time.

• Complete validation-related actions arising from change controls.

• Support root cause investigations, non-conformances, complaints and internal and external audits.

• Escalate quality or product safety concerns and identify opportunities for continuous improvement.

• Provide relevant training and guidance to colleagues across the business.

Experience and qualities that make you a strong fit:

• Practical experience of manufacturing equipment and process validation within a regulated manufacturing environment.

• A clear understanding of IQ, OQ and PQ, including the purpose, sequence and requirements of each stage.

• Around 1-2 years' relevant validation experience, with the ability to apply your knowledge in a practical manufacturing setting.

• Strong documentation skills and the ability to produce clear, accurate and compliant validation records.

• A full UK driving licence and access to a car (for office days)

Preferred:

• A degree in a scientific, medical or engineering discipline.

• Experience within medical devices, pharmaceuticals or another closely related regulated manufacturing environment.

• Experience of cleanroom monitoring, sterilisation validation, medical-device injection moulding or sterile packaging; training can be provided in these areas.

What’s on offer:

• A permanent opportunity with an established medical device manufacturer.

• Hybrid working, with 2-3 days per week based onsite in North Yorkshire.

• Broad exposure across equipment and process validation, quality, regulatory compliance and new product development.

• The opportunity to work with internal teams, suppliers and specialist external partners.

Could this be the role for you?

If you have practical manufacturing equipment and process validation experience, including an understanding of IQ, OQ and PQ, please apply or get in touch for a confidential conversation. Medical-device experience would be useful, but it is not essential where you have relevant transferable experience from a closely related regulated manufacturing environment.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Life Sciences acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we’ll be more than happy to assist.