Cleaning Validation Engineer II
Core
Execute cleaning validation activities for multi-product pharmaceutical facilities, ensuring compliance with cGMPs and regulatory standards for parenteral and solid dose products.
Role type
Senior IC Cleaning Validation Engineer
Builds
Validated cleaning processes and documentation for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cleaning validation principles, cGMP compliance, investigation and troubleshooting, data analysis and reporting, change control management, technical documentation authoring, swabbing execution, recovery studies, cross-functional collaboration, team training
Preferred skills
Experience with automation systems, facility operations, utility systems
Technologies
Microsoft Office applications
Responsibilities
Perform validation activities for equipment, utilities, facilities, processes, and automation systems; Execute cleaning validation protocols including sample collection and data recording; Compile, analyze, and interpret validation data to prepare reports; Initiate and support investigations of validation deviations; Coordinate change control activities; Author and revise validation procedures and technical documentation; Provide guidance and training to validation technicians; Resolve moderately complex validation issues
Seniority
Mid-Senior, hands-on IC
