Validation Engineer

Validation Quality Engineer Position Type: 12-Month Initial Contract (With high potential for extensions or permanent conversion) Salary: £35,000 - £66,000 per annum (Dependent on experience, entry level and seasoned professionals considered) Location: Witney, on site full time About the RoleWe are seeking a Validation Quality Engineer to join a global leader in healthcare and medical technology. In this role, you will be embedded within a highly collaborative team of 5 QA and engineering professionals, working side-by-side with the software development teams who write the code for our life-changing medical devices. Your core mission is to act as the bridge between engineering and compliance. Rather than focusing on day-to-day manufacturing operations, this position is deeply embedded within R&D and project teams. You will ensure that software development teams strictly adhere to software validation system lifecycles and medical device regulatory standards, acting as a trusted consultant on validation strategy, change control activities, and protocol execution. Our team is diverse, ranging from ambitious engineers with 2-3 years of experience to industry veterans with over 20 years of expertise. We are looking for someone with a solid foundation in regulated environments who can provide practical, proactive guidance to keep our projects moving safely and compliantly. Key Responsibilities • Project Consultation & Strategy: Embed within medical device project teams to provide strategic guidance on validation processes, helping teams navigate compliance pathways smoothly. • Lifecycle Compliance: Ensure software teams are fully complying with software validation system lifecycles and strict medical device requirements. • Protocol Development: Author, review, and execute robust validation protocols, reports, and technical documentation to meet rigorous quality standards. • Change Control Management: Provide expert guidance on validation changes and lead change control activities in accordance with established quality management system (QMS) procedures. • General QA Support: Collaborate closely with the wider Quality Assurance team to support audits, risk assessments, and continuous improvement initiatives. What We Are Looking For • Regulated Industry Experience: Experience working within a strictly regulated environment (highly prefer medical devices under ISO 13485 / FDA 21 CFR Part 820, though Pharmaceuticals or Aerospace will be considered). • Validation Background: Proven track record as a Validation Engineer with direct experience writing validation protocols. (Note: You do not need to be a software or systems specialist, but a strong understanding of general validation principles is essential). • Lifecycle & Change Control Knowledge: Solid understanding of validation system lifecycles and the impact of change control in a regulated manufacturing/design environment. • Collaborative Communicator: Ability to confidently guide, advise, and consult with software developers and project stakeholders on compliance strategy. Randstad Business Support is acting as an Employment Business in relation to this vacancy.