CSV Engineer I
Core
Ensuring GxP computerized systems are validated in compliance with regulatory standards to support gene therapy manufacturing operations.
Role type
Junior IC CSV Engineer (GxP)
Builds
Validated computerized systems for gene therapy manufacturing
Domain
Biotechnology / Gene Therapy / GxP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+), risk assessment, validation protocols (URS/FS/DS/IQ/OQ/PQ), traceability matrices, CAPA management
Preferred skills
Veeva Vault QMS, BMRAM, laboratory instrumentation validation (HPLC, UHPLC, PCR), Metasys BMS, electronic execution systems, regulatory inspection support
Technologies
Veeva Vault QMS, BMRAM, NetSuite, Waters, Agilent, Chromeleon, Softmax, Metasys, Empower, HPLC, UHPLC, PCR instruments
Responsibilities
Author, review, and execute validation deliverables for GxP computerized systems; Support CSV efforts for Veeva Vault QMS, BMRAM, and lab instruments; Perform risk assessments to determine validation approach; Manage system change control, deviations, and CAPAs; Collaborate with IT, QA, Lab Operations, and Facilities teams
Seniority
Junior, hands-on IC