Responsible for maintaining product in validated state at contract manufacturer (CM)/packager sites throughout external supply (ES) chain. Activties include: process validation studies, packaging validation studies, cleaning validation studies, equipment qualifications, shipping and bulk holding studies, stability studies, change control management, product investigations and raw material qualification. Resident SME for packaging (IOPP CPP) and cleaning issues within ES Technology group. Specialties Managing validation (process and packaging) studies Managing cleaning studies, stability studies, bulk holding studies and shipping studies Lead Investigator with regard to product investigations ES Technology Group packaging SME ES Technology Group cleaning SME Manage change control process for responsible products/CMs Technology Transfer Project Managementread more ...read less ...
Stevens Institute Of Technology
Iopp
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Senior Engineer
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