IT Validation Lead (GxP / CSV)

Location: Non-Headquarters

Department: Valspec - Engineering & Services

IT Validation Lead (GxP / CSV / AI Systems)

Location: Greater Chicago area, IL (hybrid — 3 days/week onsite)

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspecs mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

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.

What Youll Do

• 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

What You Bring

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

Details

• 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

How to Apply

If youre a validation professional ready to lead high-visibility IT and AI validation work for a major pharmaceutical organization, wed love to hear from you. Even if you dont meet every qualification listed, we encourage you to apply — strong GxP validation leadership experience matters most.