0079V6400 CSA Consultant/Senior Validation Engineer 2

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

0079V6400 CSA Consultant/Senior Validation Engineer 2

Please contact Amanda Mazza,

We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This role will work closely with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures.

Key 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 including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
• Oversee validation readiness and ensure prerequisites are met prior to formal testing
• Support change control, configuration management, and release activities
• Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance
• Provide guidance on CSA-based, risk-driven validation approaches
• Conduct periodic system compliance reviews, validation health checks, and lifecycle assessments to ensure continued validated state and ongoing regulatory compliance.
• Support periodic review activities including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance.
• Assess the compliance impact of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation.
• Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation to support risk-based compliance decisions.
• Monitor and evaluate regulatory inspection observations, internal audit findings, and compliance trends to identify opportunities for process improvement.
• Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational support.

Required Experience & Qualifications

• 5-8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs , or a combination of these domains
• Hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs , or a combination of these domains
• Strong understanding of CSA principles, CSV, and SDLC processes
• Experience authoring and/or reviewing validation documentation
• Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectations
• Ability to work independently in a fast-paced, matrixed environment
• Strong communication skills and comfort interacting with Quality and business stakeholders

Preferred Experience

• Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
• Prior role as a Validation SME, CSA Lead, or Compliance Consultant
• Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms

LOCATION

Remote

EMPLOYMENT

C2C or W2