Senior CSA Validation Engineer — Remote

Two River Consulting Partners; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Two River Consulting Partners is seeking an experienced CSA Consultant/Senior Validation Engineer to support GxP compliance across PV, Clinical, and Regulatory Affairs systems. Remote work options available with C2C or W2 employment.

The candidate will collaborate with Quality, IT, and business stakeholders to ensure systems are implemented and maintained in compliance with FDA, EMA, and ICH guidelines. Ideal candidate has 5–8 years of hands-on GxP experience, strong CSA/CSV knowledge, and a

Qualifications

• 5–8 years of hands-on GxP experience in Pharmacovigilance, Clinical, Regulatory Affairs
• Experience authoring/ reviewing validation deliverables and documentation
• Knowledge of FDA/EMA/ICH regulations and data integrity expectations

Responsibilities

• Provide CSA/CSV SME expertise across PV, Clinical, and Regulatory platforms
• Support validation lifecycle activities including plans, risk assessments, and traceability matrices
• Review and approve lifecycle documentation (URS, specs, test plans, tests)
• Oversee validation readiness and prerequisite alignment for testing
• Monitor compliance trends and participate in governance forums

Skills

CSA principles

CSV

SDLC processes

Data integrity

Communication

Independent work

Tools

QMS software

Job description

Two River Consulting Partners is seeking an experienced CSA Consultant/Senior Validation Engineer to support GxP compliance across PV, Clinical, and Regulatory Affairs systems. Remote work options available with C2C or W2 employment.

The candidate will collaborate with Quality, IT, and business stakeholders to ensure systems are implemented and maintained in compliance with FDA, EMA, and ICH guidelines. Ideal candidate has 5–8 years of hands-on GxP experience, strong CSA/CSV knowledge, and a