Validation Lead

🚨 WE ARE HIRING – VALIDATION LEAD | COREAI 🚨
📍 Location: San Francisco, CA
💼 Role: Validation Lead – CoreAI Lab Instrument Integration
🧬 Domain: Pharma / Cell & Gene Therapy (CGT)
🔹 MUST-HAVE SKILLS
Computer Systems Validation (CSV) / Computer Software Assurance (CSA)
GAMP 5
FDA 21 CFR Part 11
EU Annex 11
ALCOA+ Data Integrity
IQ / OQ / PQ Qualification
Validation Master Plans (VMP)
URS, Risk Assessments & Validation Protocols
Laboratory Instrument Integration Validation
TetraScience / Tetra Data Platform
Data Integrity & Audit Trail Validation
Test Automation & Risk-Based Testing
ServiceNow / HP ALM / Jira
🔹 KEY RESPONSIBILITIES
Define and execute CSV/CSA validation strategy for laboratory instrument integrations.
Validate scientific data pipelines and instrument interfaces through Tetra Data Platform.
Develop VMP, URS, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ principles.
Validate electronic signatures, audit trails, metadata flows, and data integrity.
Lead risk-based testing, boundary testing, and automated validation within CI/CD pipelines.
Collaborate with Analytical Development, QC, QA, IT/OT, and cloud platform teams.
Coordinate with TetraScience and laboratory instrument vendors.
Manage validation lifecycle activities, changes, releases, schema upgrades, and new instrument onboarding.
Maintain continuous state of control and inspection readiness.
🔹 PREFERRED / PLUS SKILLS
Cell & Gene Therapy (CGT) Technical Operations
Pharma / Biopharma Manufacturing & Quality
Roche CSV / Quality Management System Experience
ServiceNow & AWS Technologies
Laboratory Instruments: Flow Cytometers, Cell Counters, ddPCR, SPR/Biacore, HPLC/UPLC
LIMS / ELN / LES Integration
⚠️ IMPORTANT SCREENING REQUIREMENTS
Strong hands-on CSV/CSA validation experience in regulated pharma environments.
Deep understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+.