Test Engineer

At 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 PositionA healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s What Makes Us Roche.The Pharma Technical Operations (PT) department is establishing a Validation Team You will play a vital role in ensuring the quality, compliance, and reliability of data products that drive real-world impact on processes and products within Pharma Technical Operations (PT). You'll work in a multi-disciplinary environment, collaborating closely with data engineers, subject matter experts, and other data product teams.This crucial role focuses on the evaluation, design, development, and approval of validation documentation—including plans, protocols, and reports—for computerized systems across different domains and product lines. Beyond direct contributions, you will help develop and implement streamlined validation standards to guide data product teams across PT. This requires an individual who is highly motivated, collaborative, adaptive, and dedicated to delivering value while strictly maintaining GxP compliance and regulatory requirements.The Opportunity:Determine Validation Strategy: Define validation approaches and identify deliverables needed or impacted by GxP data product use casesDevelop & Approve Documentation: Be responsible for the evaluation, design, development, and approval of validation plans/reports; and review test plans/reports (and other deliverables)Compliance and Release: Assess, authorize, and notify that the data product is ready to go live, ensuring documentation adheres to Roche SOPs and regulatory guidanceSet Best Practices: Champion delivery of Data Products, contribute to best practices, and coach data product teams on validation approaches streamlined for data systems and processesEnsure Sustained Compliance: Support data product maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection readySupport Investigations: Support deviation investigations to identify root causes and define corrective and/or preventative actionsAudit Expertise: Support system audit/inspection preparation and execution as a subject matter expertPeriodic Review: Support data product periodic reviews according to company procedureWho You AreExperience & Education: University degree with 3+ years in IT & Software Validation (CSV/CSA, GAMP). Proven experience in building/managing data pipelines and developing data productsRegulatory Knowledge: Good knowledge of Food and Drug Administration regulations/guidance (i.e., CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices)Technical Understanding: Good understanding of system and data risk assessment, and general understanding of Agile Methodology Framework (i.e., SAFe, Scrum)—previous experience is an advantageCollaboration & Communication: Excellent verbal and written communication skills with the ability to clearly communicate complex solutions to audiences of varying technical experience and seniorityAdaptability: Able to work on co-located or remote cross-functional teams to achieve milestones and goals, with an ability to quickly adapt to an ever-changing environmentRelocation benefits not available for this position**Who we areA 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 global impact.Let’s build a healthier future, together.Roche is an Equal Opportunity Employer.