IT Validation Lead (GxP / CSV)

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

• 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.

Pulled from the full job description

• Tuition reimbursement
• Health insurance
• 401(k) matching
• Employee stock ownership plan, 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.

Join a team where your contributions matter, your development is prioritized, and your success is shared.

When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.

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., 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.