Senior Computer System Validation Engineer - INTL Brazil

Job Description

One of Insight Global's clients is seeking a Senior Computer System Validation (CSV) Engineer to lead validation strategy and execution for regulated life sciences software platforms. This role goes beyond protocol execution: it requires designing risk-based validation frameworks, qualifying automation tools, and enabling efficient, scalable validation across multiple global sites.

Key Responsibilities:

• Validation Leadership - Define and own end-to-end validation strategy, ensuring alignment with GAMP 5 and CSA principles.

• Framework Design - Architect modular validation packages that can be reused across deployments (URS, traceability matrices, IQ/OQ/PQ protocols, validation summary reports).

• Risk-Based Approach - Drive validation scope through documented risk assessments, focusing effort where patient safety and product quality are most impacted.

• Automation Enablement - Lead the qualification and use of automated testing frameworks (e.g., Playwright) to reduce manual effort and support continuous validation.

• Change Control & Compliance - Ensure all validation deliverables meet 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+) requirements, including full audit trails and e-signatures.

• Global Deployment Support - Adapt validation packages for site-specific configurations while maintaining central control and consistency.

• Cross-Functional Engagement - Partner with QA, IT, Engineering, and Product teams to align validation activities with development and release cycles.

• Training & Mentorship - Provide guidance on validation best practices, coach junior engineers, and support knowledge transfer to customer site teams.

• Continuous Validation Models - Implement processes that enable efficient re-validation for incremental releases and system updates.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• 8+ years' experience in Computer System Validation within regulated life sciences (pharma, biotech, medical devices)

• Expert knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and current CSA (Computer Software Assurance) guidance

• Demonstrated success leading validation of configurable/custom applications (GAMP Cat 4/5)

• Proven track record creating and executing URS, FS/DS, IQ/OQ/PQ, and validation summary reports

• Hands-on experience with tool qualification and automated test integration into validation processes

• Strong understanding of modern delivery environments (cloud, Kubernetes, CI/CD pipelines) and their validation implications

• Excellent technical writing skills with a portfolio of audit-ready validation deliverables

• Strong leadership, stakeholder management, and communication skills - Experience with MES, LIMS, or other manufacturing execution systems

• ERP integration validation exposure

• Familiarity with continuous validation and pre-validated software delivery models