IT Validation Lead (GxP / CSV)

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Quick Summary

Overview

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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.

Responsibilities

~1 min read

→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

Nice to Have

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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

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.

What We Offer

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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.