ppAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The 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 IT Quality and the Enterprise Cloud product teams you will help to ensure platforms are implemented and maintained 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. /ph3Your Responsibilities /h3ulliEnsure that the qualified state of platforms is maintained, keeping them audit and inspection ready. /liliEnsure that IT controls (e.g. Configuration/Change Management, Security/Access Management, Periodic Reviews, Audit Trail, Backup and Restore, Incident management, etc.) are in place using appropriate tools and in alignment with our company standards, to support the implementation and maintenance of the platform. /liliDesign, 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). /liliYour goal is to turn manual quality gates into automated, code-level checks so engineering teams can move fast without compromising regulatory standards. /liliAct as the technical bridge between DevOps/Engineering and the IT Quality Assurance (ITQA) and Validation teams. /liliServe as an expert advisor on how to translate complex pharma regulations into concrete technical implementation patterns,



pipeline guardrails, and actionable automated policies. /liliDevelop 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. /liliPartner with the team leads to modernizing traditional validation paradigms toward continuous testing and "Compliance as Code." /liliProvide 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. /liliDevelop/review/approve qualification documentation, such as qualification plans and reports according to Roche CSV SOPs. /liliReview qualification activities, ensuring that the platforms are compliant throughout their lifecycle. /liliDeliver expert guidance on IT qualification and compliance to System Owners, Process Owners, and SMEs. /liliSupport deviation investigations to pinpoint root causes, execute effective corrective and preventive actions, and represent the IT compliance team throughout internal and external audits. /li /ulh3Who You Are /h3ulliBachelor's or Master’s degree in Computer Science, Information Technology, Life Sciences, or a related field. /liliDemonstrated ability to research technical topics, learn new tools quickly, and a strong desire to develop expertise in Cloud and DevOps practices. /liliAbility to work effectively within a team, actively participating in discussions and code reviews. /lili1+ years of hands‑on experience in quality engineering (including validation and software testing) or a comparable discipline in the pharmaceutical, biotechnology, or regulated healthcare technology industry. /liliRegulatory Awareness: Understanding and experience working with regulations/guidance (e.g. FDA 21 CFR Part 11, EU Annex 11, GxP practices, etc.).



/liliFamiliarity with incident response, including supporting the adoption of ITSM processes and conducting blameless postmortems. /liliExperience supporting regulatory inspections and audits is a plus. /liliBasic understanding of core public cloud services. /liliHands‑on experience building Cloud applications via Terraform or CDK. /liliFamiliarity with Gitlab/Github, SDLC practices and CI/CD. /liliHands‑on experience using scripting languages such as Python or Bash and testing frameworks like Pytest. /liliFamiliarity with Agile methodologies (SAFe), principles, processes, and tools. /liliOpenness to using AI assistants to support learning, code generation and debugging. /liliProactive approach to troubleshooting issues and finding potential solutions. /liliEffective verbal and written communication skills. /liliProficiency in English is a must. /liliExperience working collaboratively in cross‑functional, diverse and agile teams. /liliAdaptability, problem‑solving and openness to feedback. /liliIntellectual curiosity and integrity and strong passion for innovation. /li /ulh3Who we are /h3pA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life‑changing healthcare solutions that make a integral impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche. /p /p #J-18808-Ljbffr

📌 Cloud DevOps & Validation Engineer - Roche Cloud Platform (Madrid)
🏢 F. Hoffmann-La Roche
📍 Madrid