GxP IT Validation Lead — Regulated Systems Expert

OpenKrill; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

OpenKrill is actively seeking an experienced GxP IT validation professional to lead validation engagements across life sciences clients. You will scope, write, execute, and document risk-based validation for SaaS, cloud apps, and IT infrastructure, collaborating with client QA, system owners, and our IT delivery team to establish intended use and produce defensible validation records.

You will drive validation plans, risk assessments, and testing strategies, ensure compliance with 21 CFR Part

Qualifications

• Substantial hands-on experience in GxP computerized system validation or IT quality within life sciences.
• Authoring deliverables, executing or coordinating testing, and completing approved validation packages.
• Practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles including ALCOA+, and risk-based validation methods.
• Experience validating regulated SaaS, cloud-hosted applications, or other computerized systems, with understanding of supporting IT infrastructure.
• Ability to distinguish GxP impact, intended use, and system risk, and translate those judgments into a justified validation approach.
• Experience maintaining validated systems through change control, release assessments, or periodic reviews.
• Experience supporting QA reviews, sponsor audits, supplier audits, external audits, or regulatory inspections.
• US work authorization and residence in the United States.

Responsibilities

• Lead validation engagements, define intended use and risk-based scope with client QA and system owners.
• Prepare and execute validation plans, requirements, risk assessments, test protocols, traceability records, and summaries.
• Apply risk-based CSV and computer software assurance principles using supplier documentation and testing where justified.
• Assess SaaS and cloud systems (e.g., eQMS, eSignature, LIMS, eTMF) for GxP impact.
• Plan and document qualification of IT infrastructure with technical specialists.
• Explain validation decisions and resolve client QA review comments.

Skills

GxP validation

IT quality

Technical writing

Client communication

Risk-based validation

US work authorization

Tools

Microsoft 365

SharePoint

Azure

Job description

OpenKrill is actively seeking an experienced GxP IT validation professional to lead validation engagements across life sciences clients. You will scope, write, execute, and document risk-based validation for SaaS, cloud apps, and IT infrastructure, collaborating with client QA, system owners, and our IT delivery team to establish intended use and produce defensible validation records.

You will drive validation plans, risk assessments, and testing strategies, ensure compliance with 21 CFR Part