Validation Lead

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

The Validation Lead is responsible for leading and supporting validation activities for GxP-regulated computerized systems across multiple client projects, including new implementations, system enhancements, and ongoing maintenance. This role collaborates with client stakeholders, vendors, and cross-functional teams to ensure systems comply with applicable regulatory requirements, quality standards, and company procedures.

The Validation Lead plans, coordinates, authors, reviews, and approves validation deliverables, ensuring they are completed on time and aligned with project objectives. The role provides guidance on validation strategy, oversees validation activities throughout the system lifecycle, and helps ensure computerized systems remain in a validated state while meeting client quality and compliance requirements.

Primary Responsibilities

• Lead end-to-end Computer System Validation (CSV) activities for GxP and Non-GxP applications, ensuring successful planning, execution, approval, and project closure.
• Author, review, and approve validation deliverables, including Validation Plans, URS, Functional/Configuration Specifications, Test Scripts, RTMs, VSRs, and validation packages.
• Oversee validation testing activities, including protocol execution, defect management, deviation investigation, and documentation of test results.
• Manage project timelines, resources, risks, dependencies, and deliverables to ensure validation activities are completed on schedule and within scope.
• Develop, review, and update SOPs, work instructions, and validation procedures related to computerized systems validation and system administration.
• Serve as the primary customer point of contact, managing stakeholder expectations, project communications, and overall customer satisfaction.
• Drive continuous improvement initiatives across internal and client engagements to strengthen compliance, efficiency, quality, and validation processes.
• Build and maintain strong relationships with customers, business stakeholders, vendors, quality teams, and leadership to ensure successful project outcomes.
• Provide guidance, mentoring, and oversight for validation resources and project teams as needed.
• Excellent communication skills and ability to communicate information clearly and concisely to customers.
• Willingness and ability to work with multi-functional and multi-cultural teams.
• Strong organization, planning, and time management skills, including experience in leading and managing projects

Requirements

• 8+ years of experience in a pharmaceutical, biotechnology or related environment combined with a minimum of 5 years of experience in GxP Computer System validation (CSV).
• Experience in validation of Veeva Vaults (R&D / Clinical / Commercial) is a plus.
• Strong knowledge of and experience with Computer System Validation (CSV) and regulatory requirements, including FDA, GxP, GAMP, Part 11, Annex 11, and ICH guidelines.
• Proficiency with Microsoft Office and Project Management Tools.
• Excellent verbal and written communication skills.
• Strong understanding of SaaS applications.
• Ability to work independently in a fast-paced environment.