Validation Engineer III
Core
Lead validation activities to ensure facility equipment, utilities, processes, and computerized systems are qualified and maintained in a validated state per regulatory requirements.
Role type
Senior IC Validation Engineer (cGMP)
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 compliance, validation protocol authoring, IQ/OQ/PQ execution, change control, risk assessment (FMEA), deviation investigation, CAPA management, data integrity (ALCOA+), technical writing, project management
Preferred skills
Master's degree, FDA/EMA inspection support, capital project commissioning, electronic validation systems
Technologies
Microsoft Office Suite, electronic validation systems
Responsibilities
Author and approve validation protocols and reports; Execute and oversee IQ/OQ/PQ protocols; Manage external vendors for qualification activities; Lead validation project timelines and deliverables; Review proposed changes and assess impact; Support regulatory agency inspections
Seniority
Senior, hands-on IC
