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 environment. 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.
Digital Solutions Validation Analyst in Ottawa employer: Billennium
At Billennium, we pride ourselves on fostering a dynamic and inclusive work culture that empowers our employees to excel in their roles. As a Strategic Enterprise Tech Account Executive, you'll benefit from comprehensive training programs, mentorship opportunities, and a collaborative environment that encourages innovation and professional growth. Located in North America, we offer competitive compensation packages and the chance to make a meaningful impact by driving business success for our clients.
