Validation Engineer III
Core
Lead validation activities to ensure facility equipment, utilities, processes, and computerized systems are qualified and maintained in a validated state for cGMP compliance.
Role type
Senior IC Validation Engineer (SME)
Builds
Qualified equipment, utilities, and processes for pharmaceutical, biotechnology, and medical device manufacturing
Domain
Life Sciences / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations, FDA guidance, ALCOA+ data integrity, validation protocols (IQ/OQ/PQ), change control, risk assessments (FMEA), deviation investigations, CAPA, computer system validation (CSV), cleaning validation, aseptic process simulation, utility qualification (WFI, purified water, clean steam, HVAC), environmental monitoring, technical writing, project management
Preferred skills
Master's degree, regulatory inspection support (FDA/EMA), capital project experience, equipment design and commissioning
Technologies
Microsoft Office Suite, electronic validation systems
Responsibilities
Author and approve validation protocols and reports; Establish and maintain validation master plans; Execute IQ/OQ/PQ protocols; Manage external vendors for qualification activities; Review proposed changes and provide impact assessments; Lead validation-related project activities and timelines
Seniority
Senior, hands-on IC
