Validation Analyst 2
Core
Manage validation projects for intermediate customer accounts, ensuring compliance with government and customer requirements for biopharma processes and systems.
Role type
Validation Analyst II (IC)
Builds
Validated processes and programs for biopharma customers
Domain
Biopharma / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol generation, audit assistance, change control management, deviation investigation, regulatory knowledge (cGMP, GCP, GAMP, 21CFR, Annex 11), documentation accuracy, customer communication
Preferred skills
Problem resolution, time management, decision making, goal setting
Technologies
Computer programs for complex tasks
Responsibilities
Prepare validation protocols and master validation plans, ensure documentation completion and closure, investigate validation deviations, prepare change control reports for audits, communicate project progress to management, review production jackets and standards
Seniority
Mid-level IC
