CSV Consultant

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’m looking for an experienced CSV professional to join a growing life sciences organisation and take a leading role across a portfolio of computer system validation projects.

This is a hands‑on position where you’ll help define risk-based CSV strategies, drive validation deliverables and provide expert guidance to GxP system owners. There will also be an opportunity to work on the validation and GxP assessment of AI tools and applications.

What you’ll be doing:

• Lead CSV strategy and decision‑making using a risk-based approach
• Develop validation strategies across different systems and applications
• Drive multiple validation projects and associated deliverables simultaneously
• Author Validation Plans and Summary Reports
• Support requirements, UFRS/FRS, IQ, OQ and PQ documentation
• Oversee test execution and review executed protocols
• Manage validation documentation within Veeva
• Guide, coach and train GxP system owners
• Support validation strategy for AI tools and applications

What we’re looking for:

• Strong Veeva experience, ideally across Veeva Quality, QMS and/or RIMS
• Experience validating GAMP Category 5 bespoke/custom systems
• Understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, GMP, GCP and Data Integrity
• Understanding of FDA Computer Software Assurance (CSA) principles
• Excellent technical writing and stakeholder-management skills
• Exposure to AI applications and assessing their GxP relevance would be highly valuable