Validation Lead, GxP CSV Expert

Conexus Solutions, Inc.; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Conexus Solutions, Inc. seeks a Validation Lead to drive end-to-end CSV activities for GxP and Non-GxP applications across multiple client projects.

You will ensure validation deliverables align with regulatory requirements and project objectives. You will author, review, and approve validation plans, IQ/OQ/PQ, test scripts, RTMs, and validation packages, while guiding validation strategy and ensuring the systems remain in a validated state.

Qualifications

• 8+ years in pharma/biotech with 5+ years in GxP CSV.
• Deep knowledge of FDA, GxP, Part 11, Annex 11 and ICH guidelines.
• Proficiency with project management tools and MS Office.

Responsibilities

• Lead end-to-end CSV activities for GxP and Non-GxP apps across projects.
• Author, review, and approve validation deliverables (plans, IQ/OQ/PQ, test scripts, RTMs).
• Oversee validation testing, defect management, and deviation investigations.
• Coordinate timelines, resources, risks, and scope of validation efforts.
• Develop and update SOPs and validation procedures; mentor teams.

Skills

CSV expertise

Regulatory compliance

Project management

Tools

Veeva Vault

Microsoft Project

Job description

Conexus Solutions, Inc. seeks a Validation Lead to drive end-to-end CSV activities for GxP and Non-GxP applications across multiple client projects.

You will ensure validation deliverables align with regulatory requirements and project objectives. You will author, review, and approve validation plans, IQ/OQ/PQ, test scripts, RTMs, and validation packages, while guiding validation strategy and ensuring the systems remain in a validated state.