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Area Este PR 00600 Area Este

DescripciónDescription

Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.

Requisitos Requirements Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree in Sciences and Engineering and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience. Experience working with commissioning and qualification of drug substance equipment such as tanks, bioreactors, computerized systems and analytical equipment, facilities, and utilities Must know how to read a P and ID drawing Must have an understanding of what is the C and Q process and the person must be familiar with C and Q plans, systems URS, Risk Assessments, and vendors documentation. Must know how to elaborate, handling and execute a testing protocol including the resolution of deviations Must know how to handle a GMP document Must be prepared to interact with system vendors during preparatory C and Q activities and during C and Q a

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