IT Validation Lead

Position Overview

We are seeking experienced IT Validation Leads to drive GxP computer system validation — including validation of AI-enabled solutions — for a global pharmaceutical manufacturer in the greater Chicago area. This is a 12-month contract (W2 or 1099) at $65–$80/hour with strong potential for extension, on a hybrid schedule of three days per week onsite. AI validation is one of the least-charted frontiers in GxP compliance, and this role puts you at the front of it: applying risk-based validation thinking to systems the industry is still writing the playbook for, backed by a foundation of traditional CSV work.

Multiple openings are available.

• Lead the end-to-end GxP validation lifecycle for IT systems, from user requirements and risk assessment through IQ/OQ/PQ execution and validation summary reporting
• Author, review, and approve regulated validation deliverables, including validation plans, protocols, traceability matrices, and SOPs
• Lead validation of AI-enabled solutions — shaping validation strategy, acceptance criteria, and risk-based testing approaches for AI/ML systems in alignment with GAMP 5 and emerging industry guidance
• Apply risk-based and CSA-informed approaches across traditional software validation deliverables
• Ensure audit readiness and sustained compliance with FDA, EMA, and MHRA expectations, including 21 CFR Part 11, EU Annex 11, and GAMP 5
• Coordinate cross-functionally with QA, IT, and business stakeholders to manage validation deliverables and drive testing execution to completion
• Identify compliance gaps, assess risk, and drive corrective actions to closure

Required:

• 8+ years of Computer System Validation (CSV) / IT validation experience in the pharmaceutical or life sciences industry
• Demonstrated experience leading validation efforts and approving regulated documentation, not just executing protocols
• Strong working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles
• Experience authoring the full validation document set: plans, URS, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and summary reports
• Strong cross‑functional communication skills with QA, IT, and business teams

Preferred:

• Prior experience at a large global pharmaceutical company
• Experience validating AI/ML-enabled or emerging‑technology solutions in a GxP environment — or a strong point of view on how AI systems should be qualified, informed by GAMP 5 and CSA principles
• Familiarity with Computer Software Assurance (CSA) principles

• Employment type: 12-month contract (W2 or 1099), with opportunity for extension
• Start date: Immediate start available
• Pay rate: $65–$80 per hour, depending on experience
• Location: Hybrid — 3 days per week onsite in the greater Chicago area, 2 days remote. Local candidates only; relocation assistance is not available for this role.
• Schedule: Standard business hours, Monday–Friday
• Openings: 2 positions available