Cloud DevOps & Validation Engineer

About the role

Roche is looking for a Cloud DevOps & Validation Engineer in Madrid. You will evaluate, design, develop and review qualification deliverables such as qualification plans, protocols and reports for qualified platforms in the Enterprise Cloud product area. Working with Digital Quality and the Enterprise Cloud product teams, you will help ensure platforms stay qualified under regulatory agency requirements, company standards and industry practice, and you will continuously improve internal qualification processes.

Key responsibilities

• Keep platforms audit and inspection ready and in line with regulatory compliance standards.
• Ensure IT controls (configuration and change management, security and access management, periodic reviews, audit trail, backup and restore, incident and deviation management) are in place with appropriate tools.
• Design, build and maintain automated compliance checks, continuous testing and reporting inside the CI/CD pipeline, turning manual quality gates into automated code-level checks.
• Act as the technical bridge between DevOps/Engineering and Digital QA, advising on how to turn regulation requirements into technical patterns, pipeline guardrails and automated policies.
• Develop custom scripts, hooks, CLI tools or infrastructure-as-code modules that capture execution evidence, maintain audit trails and flag compliance deviations in PRs and commit checks.
• Partner with team leads to modernize qualification toward "Compliance as Code" and coach engineers on traceable, compliant code.
• Define qualification strategies, develop and approve qualification documentation per Roche CSV SOPs, and drive validation and qualification activities to support audit readiness.
• Advise System Owners, Process Owners and SMEs on qualification and compliance, support deviation investigations and represent the IT compliance team in internal and external audits.
• Define and review compliant account migration plans.

Required profile

• Bachelor's or Master's degree in Computer Science, Information Technology, Life Sciences or a related field.
• 1+ year of hands-on experience in quality (validation and qualification) in the pharmaceutical, biotechnology or regulated healthcare technology industry.
• Ability to research technical topics, learn new tools quickly and work in cross-functional, agile teams.
• Strong English proficiency is required.

Required skills

• Understanding of regulations such as 21 CFR Part 11, EU Annex 11, GxP and ALCOA+; incident and deviation response; ITSM processes (Change and Deviation Management); regulatory inspections and audits (a plus).
• Basic understanding of core public cloud services (a plus).
• Hands-on experience building cloud applications with Terraform or CDK.
• Familiarity with GitLab/GitHub, SDLC and CI/CD (a plus).
• Scripting with Python or Bash and testing frameworks such as Pytest (a plus).
• Experience with AI assistants, code generation and debugging (a plus).