Lead CSV & GxP Validation Specialist – AI Tools

i‑Pharm Consulting; New Jersey; On-site; USD 100,000 - 180,000; Full time

Job summary

i‑Pharm Consulting is seeking an experienced CSV professional to lead a portfolio of validation projects in a growing life sciences organization in New Jersey. This hands-on role involves defining risk-based CSV strategies, delivering validation deliverables, and providing expert guidance to GxP system owners.

There is also exposure to AI tools and applications validation. You will drive strategies, author validation plans, and oversee execution across IQ/OQ/PQ cycles while maintaining

Qualifications

• Minimum strong Veeva experience with Quality, QMS or RIMS.
• Experience validating GAMP Category 5 bespoke systems.
• Understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, GMP, GCP and Data Integrity.

Responsibilities

• Lead CSV strategy and risk-based decision making.
• Develop validation strategies across systems and applications.
• Drive multiple validation projects and deliverables.
• Author Validation Plans and Summary Reports.
• Support IQ, OQ and PQ documentation and related deliverables.
• Oversee test execution and review protocols.
• Manage validation documentation within Veeva.
• Guide, coach and train GxP system owners.
• Support validation strategy for AI tools and applications.

Skills

Veeva experience

Risk-based CSV

GxP validation

Technical writing

Tools

Veeva Suite

QA/QMS tooling

Job description

i‑Pharm Consulting is seeking an experienced CSV professional to lead a portfolio of validation projects in a growing life sciences organization in New Jersey. This hands-on role involves defining risk-based CSV strategies, delivering validation deliverables, and providing expert guidance to GxP system owners.

There is also exposure to AI tools and applications validation. You will drive strategies, author validation plans, and oversee execution across IQ/OQ/PQ cycles while maintaining