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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # IT Validation Lead (GxP / CSV) - **Company:** Valspec, Inc. - **Location:** Libertyville, IL, United States - **Experience:** Expert - **Salary:** $135,200.0 - $166,400.0 - **Contract:** Temporary to permanent - **Skills:** Artificial Intelligence, Software Applications, Data Integrity, Verification and Validation (Software), System Testing, Iq/oq/pq, Information Technology, Machine Learning Operations, GXP - **Published:** July 12, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=6d42c662c619a8ac ## About the Role * 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, Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time. ## Description 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 ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [AI in Regulated Industry - Validating AI-Enabled Products with PLM and Digital Twins](https://www.wearedevelopers.com/videos/2065-ai-in-regulated-industry-validating-ai-enabled-products-with-plm-and-digital-twins) - [Startup Presentation: StorX - Future of Cloud Storage](https://www.wearedevelopers.com/videos/1176-startup-presentation-storx-future-of-cloud-storage) - [Introduction to Responsible AI: Balancing Value and Risk](https://www.wearedevelopers.com/videos/1972-introduction-to-responsible-ai-balancing-value-and-risk) - [GenAI Security: Navigating the Unseen Iceberg](https://www.wearedevelopers.com/videos/1744-genai-security-navigating-the-unseen-iceberg) ## Related Articles - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [System change: restart as developer?](https://www.wearedevelopers.com/magazine/39-system-change-restart-as-developer) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [How to Write a CV and Interview if You Don't Fully Qualify For The Job](https://www.wearedevelopers.com/magazine/183-how-to-write-a-cv-and-interview-if-you-don-t-fully-qualify-for-the-job) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated)