Senior CSA Validation Engineer (Remote)

Two River Consulting Partners; Oregon; Hybrid; USD 110,000 - 160,000; Full time

Job summary

Two River Consulting Partners seeks an experienced CSA Consultant to support GxP compliance across Pharmacovigilance, Clinical, and Regulatory Affairs systems. You will work with Quality, IT and business stakeholders to ensure systems are implemented, maintained and operated in regulatory alignment.

The role requires CSA/CSV expertise, validation deliverables development, and guidance on risk-driven validation approaches, with emphasis on ALCOA+ and data integrity practices.

Qualifications

• 5–8 years of hands-on experience supporting GxP systems in PV, Clinical, Regulatory Affairs, or similar domains.
• Strong understanding of CSA, CSV, and SDLC processes.
• Experience authoring and reviewing validation documentation.
• Knowledge of FDA/EMA/ICH data integrity expectations.
• Ability to work independently in a fast-paced, matrixed environment.

Responsibilities

• Provide CSA/CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms.
• Support system implementations, enhancements, integrations, upgrades and data migrations from a compliance perspective.
• Develop and review validation deliverables: Validation Plans, Risk Assessments, Traceability Matrices, Validation Summary Reports.
• Review lifecycle documentation (URS, specs, test plans, test summaries) per ALCOA+ and GxP.
• Oversee validation readiness and prerequisites before testing; support change control, configuration management, and release activities.
• Collaborate with Quality, System Owners, and Business Process Owners to maintain ongoing compliance.
• Offer guidance on CSA-based, risk-driven validation approaches; conduct periodic reviews and health checks.
• Support user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance.

Skills

GxP knowledge

CSA principles

CSV & SDLC

Job description

Two River Consulting Partners seeks an experienced CSA Consultant to support GxP compliance across Pharmacovigilance, Clinical, and Regulatory Affairs systems. You will work with Quality, IT and business stakeholders to ensure systems are implemented, maintained and operated in regulatory alignment.

The role requires CSA/CSV expertise, validation deliverables development, and guidance on risk-driven validation approaches, with emphasis on ALCOA+ and data integrity practices.