We’re looking for a Lead CSV / CSA Specialist to drive validation strategy and compliance for cloud-based data platforms, including Azure Databricks, within a GxP-regulated environment.
This is a high-impact opportunity to shape how modern data platforms are validated—moving beyond traditional documentation toward risk-based Computer Software Assurance (CSA) approaches aligned with GAMP 5, 21 CFR Part 11, and EU Annex 11.
🔹 What You’ll Do
- Define and lead Validation Master Plans (VMP) for cloud and data platforms
- Own CSA-based validation strategies and risk assessment frameworks
- Author and review:
- URS / FRS / TRS
- Risk Assessments
- Traceability Matrices
- Design IQ / OQ / PQ frameworks for modern technology platforms
- Lead validation activities for:
- Data pipelines
- Analytics workflows
- Cloud infrastructure
- AI/ML systems (optional)
- Define change control and revalidation strategies
- Partner with QA, Engineering, and Business teams to ensure compliance by design
- Support audit readiness, deviations, and CAPA activities
🔹 What We’re Looking For
- 8–12 years of experience in GxP-regulated environments (GMP / GLP / GCP)
- Strong expertise in:
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- Deep knowledge of:
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Experience validating:
- Cloud platforms and/or data & analytics platforms
- eQMS, LIMS, ELN, or similar GxP systems
⭐ Nice to Have
- Exposure to Azure Databricks, Snowflake, or modern data platforms
- Understanding of:
- IAM / RBAC / SSO
- Data lineage and audit logging
- CI/CD and controlled releases
- Experience with AI/ML validation
- Experience supporting regulatory audits and inspections
- Knowledge of Data Integrity / ALCOA+
- Experience with FMEA-based risk assessments