Senior Computer Systems Validation Engineer

Essential Functions

• Hands-on lead full lifecycle Computer System Validation activities for cloud based GxP systems including databases, and applications.
• Author, update, execute and maintain validation deliverables such as Validation Plans, User Requirements, Functional Specifications, Risk Assessments, Traceability Matrices, IQ, OQ, PQ protocols, and Summary Reports.
• Perform risk assessments to define validation scope, testing strategy, and documentation requirements in alignment with CSA principles.
• Define and execute validation strategies for data platforms and system components, ensuring systems meet defined functional, security, and data integrity requirements.
• Assess and validate end to end data flows between upstream source systems and downstream applications to ensure accuracy, completeness, and traceability.
• Evaluate system changes for validation impact and ensure validated systems remain compliant through appropriate testing and documentation.
• Ensure validation activities align with automated build and deployment pipelines, confirming that system releases maintain validated state and appropriate validation evidence is generated.
• Support change control, deviation management, periodic review, and lifecycle management of validated systems.
• Participate in internal audits and regulatory inspections, providing validation documentation and rationale as required.
• Contribute to continuous improvement of validation procedures aligned with evolving CSA guidance and cloud delivery models.

Requirements

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience.
• Minimum 7 years of experience in Computer System Validation within biotech manufacturing and lab data systems. Other combinations of education and/or experience may be considered.
• Must have technical knowledge of IT infrastructure, software engineering, programming, databases and data integrations.
• Experience working in modern system environments utilizing CI/CD pipelines or automated release processes.
• Strong hands-on experience validating GAMP 5 systems for biotech manufacturing.
• Deep understanding of FDA 21 CFR Part 11, Part 210, Part 211, Annex 11, data integrity requirements, and risk-based validation methodologies.
• Strong technical writing skills and ability to create comprehensive validation documentation.
• Able to communicate validation risks and requirements clearly to IT and Quality stakeholders.

Preferred Qualifications

• Hands-on experience validating cloud based GxP systems, specifically Azure.
• Familiarity with infrastructure as code frameworks like GitHub, Terraform etc.
• Experience applying CSA principles to custom data applications in GxP cloud.
• Microsoft Azure or similar technical certifications.