0079V6400 CSA Consultant/Senior Validation Engineer 2

Two River Consulting Partners; Pennsylvania; Remote; USD 120,000 - 160,000; Full time

Job summary

Two River Consulting Partners seeks an experienced CSA Consultant/Senior Validation Engineer to deliver CSA/CSV expertise across PV, Clinical, and Regulatory Affairs platforms in a remote, US-based role. You will support system implementations, enhancements, and data migrations from a compliance perspective, while developing validation deliverables and lifecycle documentation.

The position requires 5–8 years of hands-on GxP experience, strong knowledge of CSA/CSV and SDLC, and the ability to

Qualifications

• 5–8 years 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.

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.

Skills

CSA principles

CSV

SDLC processes

Validation documentation

GxP regulations knowledge

Independent work

Communication skills

Tools

ALM tools

Change management tools

Job description

0079V6400 CSA Consultant/Senior Validation Engineer 2

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