BioSpace
US - Illinois - North Chicago
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The Software Engineer will design, implement, and optimize system integrations for Quality and GxP-regulated computer software. The role involves ensuring robust data flows across LIMS, QMS, and enterprise platforms while maintaining regulatory compliance.
Requirements: Requires a Bachelor's or Master's degree with at least 5 years of experience in IT or software engineering, specifically within GxP/Quality system integration. Proficiency in API technologies, software validation standards like GAMP 5, and cloud platforms is essential.
Key Skills: System Integration, GxP Compliance, REST/SOAP APIs, ETL Tools, Software Validation, GAMP 5, 21 CFR Part 11, SDLC, Cloud Computing, AWS, Azure, LIMS, QMS, Technical Documentation, Cross-functional Leadership, Risk-based Validation
Benefits: Paid time off, Vacation, Holidays, Sick leave, Medical insurance, Dental insurance, Vision insurance, 401(k), Short-term incentive programs
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