Senior CSV Consultant — Regulated Validation Lead

Planet Group; Bridgewater Township (NJ); Hybride; USD 118 000 - 125 000; Temps partiel

Résumé du poste

Planet Group is seeking an experienced Senior CSV Consultant to lead validation activities across multiple GxP computerized systems in a Bridgewater, NJ hybrid setting. You will drive risk-based validation strategies and ensure systems stay in a validated state, in line with SOPs and regulatory requirements.

The ideal candidate has extensive hands-on CSV experience, strong knowledge of Veeva systems, and experience validating custom-built applications and AI technologies in regulated

Qualifications

• 5-10+ years of hands-on CSV experience in a regulated GxP environment.
• Strong experience validating Veeva platforms, including Veeva Quality, Veeva QMS, Veeva RIMS.
• Experience validating GAMP 5 (custom-built/bespoke) computerized systems.
• Experience evaluating AI tools and applications, including assessing GxP relevance and validation requirements.
• Strong working knowledge of FDA and EU regulations and industry standards (21 CFR Part 11, EU Annex 11, GAMP 5, GMP, GCP).
• Understanding of FDA CSA (Computer Software Assurance) principles and risk-based validation approaches.
• Strong technical writing skills for authoring, reviewing, and approving validation documentation.
• Ability to lead multiple projects, prioritize deliverables, and collaborate with cross-functional stakeholders.
• Excellent communication and stakeholder management skills.

Responsabilités

• 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.

Description du poste

Planet Group is seeking an experienced Senior CSV Consultant to lead validation activities across multiple GxP computerized systems in a Bridgewater, NJ hybrid setting. You will drive risk-based validation strategies and ensure systems stay in a validated state, in line with SOPs and regulatory requirements.

The ideal candidate has extensive hands-on CSV experience, strong knowledge of Veeva systems, and experience validating custom-built applications and AI technologies in regulated