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Engineer at Flexible & Integrated Technical Services, LLC

Department: Medical Device

Location
Añasco, Puerto Rico
Type
Contract
Level
not_specified
Posted

Description

FITS is seeking a Validation Services professional for Engineering and Manufacturing, with a focus on pharmaceutical and medical-device quality activities. The role involves writing, executing, and maintaining validation protocols; ensuring compliance with FDA requirements; integrating protocols into manufacturing processes; maintaining quality-system documentation; investigating product, batch, and validation-related failures; developing investigation documentation; and supporting process operations. The position requires a bachelor's degree in engineering, prior validation-quality experience in pharmaceutical or medical-device industries, bilingual Spanish and English communication, and experience with SOP development, validation documentation, GMP, and GDP. The schedule is administrative and varies according to business needs.

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