Validation Engineer

Randstad; Witney; On-site; GBP 35,000 - 66,000; Full time

Job summary

Randstad is seeking a Validation Quality Engineer for a 12-month initial contract in Witney. You will be embedded with R&D and software teams, ensuring software validation processes meet ISO 13485 / FDA‑regulated requirements and supporting regulatory compliance.

The role involves writing and reviewing validation protocols, participating in change control, and collaborating with QA to support audits and risk assessments.

Qualifications

• Experience working in a strictly regulated environment (medical devices ISO 13485 / FDA 21 CFR Part 820 preferred).
• Proven track record as a Validation Engineer with hands-on validation protocol writing.
• Strong understanding of software validation lifecycles and regulatory requirements.
• Ability to guide software developers and project stakeholders on compliance strategy.

Responsibilities

• Embed within medical device project teams to guide validation processes and compliance pathways.
• Ensure software development teams adhere to software validation lifecycles and regulatory standards.
• Author, review, and execute validation protocols, reports, and documentation to meet quality requirements.
• Lead change control activities and provide expertise on validation changes within QMS procedures.
• Support audits, risk assessments, and continuous improvement initiatives with the QA team.

Skills

Regulated environment experience

Validation protocols

Lifecycle & Change Control

Collaborative communicator

Job description

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 Role

We 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.