Digital validation and GMP expertise define this Validation Analyst role supporting regulated life sciences solutions at Roche. Work across technology, quality, and business processes.
The Validation Analyst develops validation strategies for digital solutions within Roche’s regulated setting. You will create plans and protocols, assess risks, and coordinate testing with cross-functional teams and QA SMEs. The work covers data pipelines, interfaces, automation applications, data-driven models, and statistical tools.
Key Responsibilities: Develop validation strategies aligned with regulatory and Roche standards
Create validation plans and protocols for digital solutions
Conduct GMP risk assessments and define mitigation strategies
Execute testing, analyze results, and document findings




Maintain validation and change control documentation
Requirements: Understand software development lifecycle models and business applications
Know validation principles and practices in GMP environments
Experience validating digital solutions and Release Management controls
Know GxP requirements and validation documentation standards
Familiarity with test automation processes and development
Apply validation strategy, GMP compliance, risk assessment, and testing expertise to Roche’s digital solutions and documentation activities.

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📌 Digital Solutions Validation Analyst (Manitoba)
🏢 Billennium
📍 Manitoba