Senior CSV Consultant

Senior CSV Consultant

12 month contract

Location: Bridgewater, NJ Hybrid

Pay range: $86-91/hr

Position Summary

We are seeking an experienced Senior Computer Systems Validation (CSV) Consultant to lead and support validation activities across multiple GxP computerized systems. This individual will drive CSV deliverables, develop risk-based validation strategies, and ensure computerized systems are implemented, maintained, and remain in a validated state in accordance with established SOPs, regulatory standards, and security requirements.

The ideal candidate will have extensive hands-on CSV experience, strong knowledge of Veeva systems, and experience validating custom-built applications and emerging AI technologies within regulated environments.

Key Responsibilities

• Lead CSV activities across multiple projects, providing strategic guidance and oversight throughout the validation lifecycle.

• Develop and execute risk-based CSV strategies for various systems and applications, including AI tools and technologies.

• Author and review validation documentation, including Validation Plans, Requirements (UFRS/FRS), IQ/OQ/PQ protocols, specifications, and Validation Summary Reports.

• Ensure project teams follow established CSV plans, procedures, and regulatory requirements.

• Provide real-time oversight during test execution, review completed protocols, and resolve validation-related issues.

• Coordinate document reviews, approvals, and maintenance of CSV documentation within Veeva.

• Ensure project team members complete required training related to CSV SOPs, test execution, and documentation practices.

• Provide guidance, training, and mentorship to GxP system owners and cross-functional project teams.

• Manage competing priorities and drive timely completion of validation deliverables across multiple projects.

• Ensure computerized systems remain compliant and in a validated state throughout their lifecycle.

Required Qualifications

• 5-10+ years of hands-on Computer Systems Validation (CSV) experience within a regulated GxP environment.

• Strong experience validating Veeva platforms, including Veeva Quality, Veeva QMS, Veeva RIMS, and related systems.

• Experience validating GAMP Category 5 (custom-built/bespoke) computerized systems.

• Experience evaluating AI tools and applications, including assessing GxP relevance and associated validation requirements.

• Strong working knowledge of applicable FDA and EU regulations and industry standards, including:

• 21 CFR Part 11

• EU Annex 11

•

GAMP 5

• GMP and GCP

• Data Integrity requirements

• Understanding of FDA Computer Software Assurance (CSA) principles and risk-based validation approaches.

• Strong technical writing skills, including authoring, reviewing, and approving validation documentation.

• Demonstrated ability to lead multiple projects, prioritize deliverables, and collaborate with cross-functional stakeholders.

• Excellent communication, problem-solving, and stakeholder management skills.

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.