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.

You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. 

Job description:

Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field

Minimum 3+  years experience in IT & Software Validation (CSV/CSA, GAMP)

Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) 

Good understanding of system and data risk assessment

General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage.

Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals

Effective communicator with excellent verbal and written communication skills - English language mandatory 

Assertiveness and  ability to work with diverse personalities/cultures

Let’s find out what a usual day of work might look like. You will:

Determine validation approaches, and identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems

Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance

Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live

Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures

Support in deviation investigations to identify root causes and define corrective and/or preventative actions

Support system audit/inspection preparation and execution as CSV subject matter expert

Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready

Support system periodic reviews according to company procedure

We offer:

dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.)

a workplace that supports innovation and new ideas

attractive benefits & business travel opportunities 

work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow

A 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.