Description

Writing and execution of validation protocols and reports (i.e. IQ, OQ, PQ, etc.) • Developing and implementing manufacturing processes, preparation of specifications and operator • instructions, process studies, production readiness, investigations, root cause analysis, problem solving • and report or presentation preparation. • Updating procedures, manufacturing specifications, bills, routes and travelers for product & process • changes in the PLM system. • Working with OEM equipment manufacturers and distributors to develop user requirements. • Work on new asset commissioning · Working with multi-functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals. · Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects. · Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors. • Skills: EIS : Medical Device & Regulations ~ EIS : Manufacturing Engineering Support

Key Skills

Education

Bachelor's degree