Cloud DevOps & Validation Engineer

Roche; Madrid; On-site; EUR 70,000 - 90,000; Full time

Job summary

Roche recherche un spécialiste conformite IT pour assurer l’évaluation, la conception et la revue des livrables de qualification pour des plateformes dans le domaine Cloud d’entreprise. Vous travaillerez avec les équipes Digital Quality et Enterprise Cloud afin d’assurer que les plateformes restent qualifiées selon les exigences réglementaires et les standards internes.

Ce rôle implique la conception de scripts, l’automatisation des contrôles et le soutien aux audits et inspections, tout en

Qualifications

• Connaissance des pratiques de qualité et de conformité (GxP, CSV).
• Capacité à concevoir et mettre en œuvre des contrôles automatisés dans CI/CD.
• Expérience dans le support des inspections et audits réglementaires.

Responsibilities

• Maintenir l’état qualifié des plateformes et assurer l’auditabilité.
• Concevoir et déployer des contrôles de conformité automatisés dans le pipeline CI/CD.
• Servir de passerelle technique entre DevOps et QA numérique et traduire les exigences réglementaires en pratiques techniques.
• Développer des scripts et outils pour capturer des preuves d’exécution et tracer les audits.
• Guider les équipes dans l’évolution du “Compliance as Code” et former les ingénieurs.
• Garantir les plans et rapports de qualification selon les SOP Roche CSV.

Skills

Cloud/DevOps

CI/CD

Python/Bash

GitLab/GitHub

Automatisation tests

Réglementation

Audit readiness

Communication

Education

Bachelor/Master informatique ou sciences de la vie

Tools

Terraform/CDK

GitLab

CI/CD tooling

Job description

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La position

In Roche, compliance is our license to operate so we are committed to the quality of the product we deliver. Everyone's contribution will have an impact on patients, so in everything we do, we think about patient safety.

You will be responsible for the evaluation, design, development and creation/review/approval of qualification deliverables such as qualification plans, protocols and reports for qualified platforms in the Enterprise Cloud product area.

In liaison with Digital Quality and the Enterprise Cloud product teams you will help to ensure platforms are implemented and maintained qualified in accordance with the appropriate regulatory agency requirements, our company standards, and current industry practices. You will continuously assess/review internal qualification processes and procedures, making recommendations for improvements.

Your Responsibilities

• Ensure that the qualified state of platforms is maintained, keeping them audit and inspection ready. Ensure that IT controls (e.g. Configuration/Change Management, Security/Access Management, Periodic Reviews, Audit Trail, Backup and Restore, Incident management, Deviation Management, etc.) are in place using appropriate tools and in alignment with our company standards, to ensure the platform meets regulatory compliance standards.
• Design, build, and maintain automated compliance checks, continuous testing, and reporting directly within the CI/CD pipeline (e.g., automated execution of qualification/validation test suites, static code analysis for security and compliance, automated release documentation generation, etc.). Your goal is to turn manual quality and qualification gates into automated, code-level checks so engineering teams can move fast without compromising regulatory and company standards.
• Act as the technical bridge between DevOps/Engineering and the Digital Quality Assurance (Digital QA). Serve as an expert advisor on how to translate complex regulation requirements into concrete technical implementation patterns, pipeline guardrails, and actionable automated policies.
• Develop custom scripts, hooks, CLI tools, or infrastructure-as-code modules that dynamically capture execution evidence, maintain immutable audit trails, and automatically flag compliance deviations or non-conformances directly within active developer workflows (PRs/commit checks) before code hits production.
• Partner with the team leads to modernizing traditional qualification toward "Compliance as Code." Provide ongoing coaching to software and infrastructure engineers on best practices for traceable, compliant code authoring while reducing friction and lead time for high-regulated software deliverables.
• Define qualification strategies and develop/review/approve qualification documentation, such as qualification plans and reports according to Roche CSV SOPs. Review qualification activities, ensuring that the platforms are compliant throughout their lifecycle.
• Drive the execution of validation and/or qualification activities in alignment with established best practices, governance and frameworks for CSV/CSA by Quality and regulatory bodies to support audit and inspection readiness.
• Deliver expert guidance on IT qualification and compliance to System Owners, Process Owners, and SMEs to support organizational understanding of qualification best practices, governance framework and compliance standards. Support deviation investigations to pinpoint root causes, execute effective corrective and preventive actions, and represent the IT compliance team throughout internal and external audits.
• Define and review compliant account migration plans, ensuring alignment with organizational governance and external regulatory frameworks

Who You Are

Educational background

• Bachelor's or Master’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
• Demonstrated ability to research technical topics, learn new tools quickly, and a strong desire to develop expertise in Cloud and DevOps practices.
• Ability to work effectively within a team, actively participating in discussions and code reviews.

Experience

• 1+ years of hands-on experience in quality (including validation and qualification) in the pharmaceutical, biotechnology, or regulated healthcare technology industry.

Technical Expertise

• Regulatory Awareness: Understanding and experience working with regulations/guidance (e.g. 21 CFR Part 11, EU Annex 11, GxP practices, ALCOA+, etc.)
• Familiarity with incident and deviation response
• Experience in supporting the adoption of ITSM processes (Change Management, Deviation Management, etc).

• Experience supporting regulatory inspections and audits is a plus.
• Basic understanding of core public cloud services is a plus
• Hands-on experience building Cloud applications via Terraform or CDK.
• Familiarity with Gitlab/Github, SDLC practices and CI/CD is a plus.
• Hands-on experience using scripting languages such as Python or Bash and testing frameworks like Pytest.
• Experience in using AI assistants ,
• Experience in code generation and debugging.
• Proactive approach to troubleshooting issues and finding potential solutions.

Required Skills

• Effective verbal and written communication skills. Proficiency in English is a must.
• Experience working collaboratively in cross-functional, diverse and agile teams.
• Adaptability, problem-solving and openness to feedback.
• Intellectual curiosity and integrity and strong passion for innovation.

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.