2 days ago
Madrid, SpainEntry Level
Responsibilities
- Develop and review qualification plans, protocols, reports, and validation strategies for enterprise cloud platforms.
- Maintain platforms in a qualified, audit-ready state with appropriate configuration, security, access, backup, incident, deviation, and audit-trail controls.
- Build automated compliance checks, continuous testing, security and compliance analysis, release documentation, and reporting within CI/CD pipelines.
- Create scripts, hooks, CLI tools, and infrastructure-as-code modules that capture execution evidence, maintain immutable audit trails, and identify compliance deviations.
- Bridge DevOps and Digital QA by translating regulatory requirements into technical implementation patterns, pipeline guardrails, and automated policies.
- Support CSV/CSA qualification and validation activities, deviation investigations, corrective and preventive actions, audits, inspections, and compliant account migration planning.
- Coach software and infrastructure engineers on traceable, compliant code authoring and qualification best practices.
Requirements
- Bachelor’s or master’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
- At least 1 year of hands-on quality, validation, or qualification experience in the pharmaceutical, biotechnology, or regulated healthcare technology industry.
- Understanding of 21 CFR Part 11, EU Annex 11, GxP practices, ALCOA+, incident and deviation response, and ITSM processes.
- Hands-on experience building cloud applications with Terraform or CDK.
- Hands-on experience with scripting languages such as Python or Bash and testing frameworks such as Pytest.
- Familiarity with GitLab or GitHub, software development lifecycle practices, and CI/CD.
- Experience supporting regulatory inspections and audits, understanding of core public cloud services, and experience using AI assistants, code generation, and debugging are preferred.
- Strong English communication, teamwork, troubleshooting, adaptability, problem-solving, integrity, and openness to feedback are required.
About Roche
Roche is a Swiss healthcare company that develops and sells prescription pharmaceuticals and in vitro diagnostic systems for hospitals, laboratories, and clinicians. Its business spans two core divisions—Pharmaceuticals and Diagnostics—with strengths in oncology, immunology, neuroscience, infectious diseases, and diabetes care. Founded in 1896 and headquartered in Basel, Switzerland, Roche also advances personalized healthcare by pairing therapies with companion diagnostics.