IT Validation Lead (GxP / CSV)

Valspec; Makkah Region; On-site; SAR 698,355,661 - 859,514,660; Part time

Benefits offered by this job

ESOP participation

Premium medical coverage

401(k) with company match

Job summary

Valspec is seeking experienced IT Validation Leads to drive GxP computer system validation, including AI‑enabled solutions, for a global pharmaceutical manufacturer. This is a 12‑month contract (W2 or 1099) at $65–$80/hour with strong extension potential, on a hybrid schedule of three days per week onsite in the Greater Chicago area.

You will lead end‑to‑end validation, author and approve regulated deliverables, and coordinate with QA, IT, and business stakeholders to ensure compliance with FDA,

Qualifications

• 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.

Responsibilities

• Lead the end‑to‑end GxP validation lifecycle for IT systems, from user requirements through IQ/OQ/PQ execution and summary reporting.
• Author, review, and approve regulated validation deliverables including plans, protocols, traceability matrices, and SOPs.
• Lead validation of AI‑enabled solutions, shaping strategy, acceptance criteria, and risk-based testing for AI/ML systems per GAMP 5 and CSA guidance.
• Apply risk-based and CSA-informed approaches across traditional software validation deliverables.
• Ensure audit readiness and sustained compliance with FDA, EMA, and MHRA including 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Coordinate with QA, IT, and business stakeholders to manage validation deliverables and drive testing to completion.
• Identify compliance gaps, assess risk, and drive corrective actions to closure.

Skills

CSV/IT validation

GxP validation leadership

21 CFR Part 11

GAMP 5

AI/ML validation awareness

Cross-functional communication

Job description

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 help its clients meet capital project and lifecycle maintenance goals and to ensure that life‑changing drugs remain available while streamlining production processes.

Location: Greater Chicago area, IL (hybrid – 3 days per week onsite)

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. 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
• 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
• Pay rate: $65–$80 per hour, depending on experience
• Schedule: Standard business hours, Monday–Friday

Why Join Valspec?

At Valspec, we offer 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. Our benefits package includes:

• Premium medical coverage
• 401(k) with company match
• Additional benefits designed to support your growth, well‑being, and future.

We encourage you to apply even if you don’t meet every qualification – strong GxP validation leadership experience matters most.

Equal Employment Opportunity Statement

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug‑Free Workplace.