Project Engineer

Flexible & Integrated Technical Services, LLC

📍 Añasco, Añasco, Puerto Rico

Full-time Engineers

Job Description

For Validation services in the Project Engineeirng/Medical Device Packaging area.


WHAT MAKES YOU A FIT:  The Technical Part: Bachelor’s Degree in Engineering and at least four (4) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry.

  • , Bilingual (Spanish and English) Shift: Administrative & according to business needs  Experience in: Packaging validation and testing activities for sterile and non-sterile medical device packaging systems.


    Engineering documentation, data collection, technical reports, protocols, specifications, and change records.


    Manufacturing processes, engineering concepts, and problem-solving methodologies.


    FDA QSR, ISO 13485, ISO 9001, GMP environments, MDR, and CMDR requirements (preferred).


    Validation activities, laboratory testing, statistical analysis, and risk assessments (preferred).


    Medical...

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