Senior Computer System Validation (CSV) Engineer
Core
Lead validation activities for GxP-regulated systems in an advanced therapeutics facility, ensuring compliance with regulatory frameworks and supporting data integrity programs.
Role type
Senior Computer System Validation (CSV) Engineer
Builds
Validated software and equipment systems for therapeutic manufacturing
Domain
Life Sciences / Pharma / Biotech / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GAMP 5, data integrity, regulatory frameworks (FDA 21 CFR Part 11, EU Annex 11), validation of ERP/LIMS/QMS/equipment software, IQ/OQ/PQ execution, risk assessment, traceability matrix creation
Preferred skills
Experience in pharma, biotech, or medical devices, training staff, promoting quality culture
Technologies
ERP, LIMS, QMS
Responsibilities
Lead validation activities (IQ/OQ/PQ) across GxP-regulated systems, Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Partner with IT, QC, and business teams to meet user and regulatory needs, Author and review validation plans, risk assessments, and traceability matrices, Contribute to data integrity programs and support audits
Seniority
Senior, hands-on IC