IT Validation Lead (GxP / CSV)

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.

What You'll 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
• 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 you're a validation professional ready to lead high-visibility IT and AI validation work for a major pharmaceutical organization, we'd love to hear from you. Even if you don't meet every qualification listed, we encourage you to apply — strong GxP validation leadership experience matters most.

About Valspec

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, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Why Join Valspec?

• At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership.
• As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation.
• We also offer a highly competitive benefits package, including:
• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• And more — all designed to support your growth, well-being, and future.

Equal Opportunity Employer

We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.