GxP IT Validation Lead for AI/ML & CSV

Valspec; Makkah Region; Hybrid; 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 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,