Senior Validation Engineer - CSV (OT)
Core
Leading and executing validation activities for manufacturing processes, equipment, computerized systems, and automation control systems to ensure compliance with regulatory requirements and internal quality standards.
Role type
Senior Validation Engineer (CSV/OT)
Builds
Validated manufacturing equipment, facilities, utility, automation, and computerized systems for pharmaceutical/biotech production
Domain
Pharmaceutical/Biotechnology Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP principles, risk management, validation master plans, DQ/IQ/OQ/PQ protocols, regulatory compliance (FDA/EMA), Process Automation Systems, DCS, MCS, PLC, BAS, server administration, network infrastructure
Preferred skills
NetApp storage technologies, large-scale biochemical manufacturing equipment validation
Responsibilities
Oversight and performance of Commissioning and Qualification for computerized equipment and systems; Author, review, and approve validation master plans, protocols, reports, deviations, and change controls; Develop and execute validation protocols for new and modified equipment and processes; Peer review validation protocols and reports; Provide technical leadership on project teams; Support internal and external audits
Seniority
Senior, hands-on IC