RFD_Validation Analyst 1
Core
Own validation projects for limited-risk biopharma customers, ensuring compliance with government and customer requirements through protocol generation, execution, and documentation.
Role type
Junior validation analyst (limited risk projects)
Builds
Validated processes and programs for new customer/product/system launches
Domain
Biopharmaceutical manufacturing and quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
validation protocol preparation, validation documentation management, audit support, change control reporting, deviation investigation, regulatory standards interpretation
Preferred skills
packaging and pharmaceutical background, HVAC/utility system familiarity, computer system validation experience
Technologies
cGMP, GCP, GAMP, 21CFR Part 11, Annex 11
Responsibilities
Generate and execute validation protocols, prepare validation statements and master plans, coordinate internal and customer approvals, investigate validation deviations, prepare change control and validation history reports
Seniority
Entry-level, individual contributor
