Validation Engineer II
Core
Develop, execute, and implement validation documentation and protocols to ensure the safe and orderly handover of equipment, facilities, and utilities, guaranteeing operability in performance, reliability, and safety.
Role type
Validation Engineer
Builds
Commissioning and qualification deliverables for equipment, facilities, utilities, and automation systems
Domain
Pharmaceutical/Medical Device manufacturing and quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation documentation (SOPs, IQ/OQ/PQ protocols), regulatory compliance (FDA cGMP), project management, root cause analysis, CAPA implementation, temperature mapping, clean validation, CMMS system usage
Preferred skills
Experience in healthcare, nutritional products, laboratory diagnostics, medical devices, or pharmaceutical industries
Technologies
Kneat paperless qualification system, CMMS (Computer Maintenance Management System)
Responsibilities
Develop and execute validation protocols for autoclaves and control temperature units; plan and conduct small to medium validation projects across facilities and utilities; manage concurrent projects and meet deadlines; process EWR/EIR records and support equipment release in CMMS; support Quality Investigations and CAPA; support site Cleaning Validation program.
Seniority
Mid-level, hands-on IC