Cleaning Validation Specialist
Core
Coordinate cleaning validation activities, execute protocols, and investigate deviations for pharmaceutical manufacturing equipment.
Role type
Cleaning Validation Specialist
Builds
Cleaning validation studies and reports for drug substance manufacturing processes
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cleaning validation protocols, deviation investigation, sampling and testing, data analysis, GMP compliance, equipment design interpretation, technical writing, risk assessment, project management
Preferred skills
Continuous process improvement, validation sample management lifecycle, troubleshooting, leadership, time management, regulatory knowledge (cGMP, OSHA, FDA)
Technologies
PI, KNEAT
Responsibilities
Support authoring and executing CV/CHT/SHT protocols, perform on-floor CV execution and sampling, design cleaning procedures for new products, conduct cleaning validation studies including data analysis, investigate and troubleshoot cleaning deviations, train manufacturing and QC/QA personnel
Seniority
Mid-level, hands-on IC
