Senior Computer Systems Validation Engineer
Core
Leading validation activities for cloud-based GxP systems to ensure regulatory, quality, and operational compliance throughout the system lifecycle.
Role type
Senior Computer Systems Validation Engineer
Builds
Validated cloud infrastructure, databases, and integrated applications for biotech vaccine development
Domain
Biotechnology / Pharmaceutical / GxP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), Computer Software Assurance (CSA), GAMP 5, risk assessment, data integrity, CI/CD pipelines, SQL/relational databases, cloud infrastructure validation, technical writing, regulatory compliance (FDA 21 CFR Part 11, 210, 211, Annex 11)
Preferred skills
Azure cloud validation, Infrastructure as Code (Terraform, GitHub), CSA principles for custom data applications, Microsoft Azure certifications
Technologies
Azure, GitHub, Terraform, CI/CD pipelines, relational databases
Responsibilities
Lead full lifecycle CSV activities for cloud GxP systems; Author and execute validation protocols (IQ, OQ, PQ) and traceability matrices; Perform risk assessments to define validation scope; Validate end-to-end data flows between source systems and applications; Evaluate system changes for validation impact; Support change control, deviation management, and lifecycle management; Participate in internal audits and regulatory inspections
Seniority
Senior, hands-on IC