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GxP Lab Systems Integration Test Engineer at iTech US Inc (South San Francisco, CA, United States) — On-Site QA Job
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Role Overview & Requirements Job Overview
We are seeking an experienced GxP Lab Systems Integration Test Engineer to support the testing and validation of laboratory instrument integrations within regulated pharmaceutical and life sciences environments. The role involves validating data pipelines connecting laboratory instruments to enterprise applications such as LIMS, LES, ELN, and Data Lakes through modern data integration platforms. Required Qualifications & Skills
GxP Lab Systems Integration Test Engineer
Laboratory Informatics Experience
Hands-on testing experience with laboratory applications such as LIMS, CDS, ELN, or SDMS.
Understanding of analytical laboratory workflows within pharmaceutical R&D, Quality Control (QC), or regulated life sciences environments.
Data Integration & Interface Testing
Experience testing APIs, system interfaces, and end-to-end data pipelines.
Understanding of data structures and formats such as JSON and XML.
Experience validating data mapping, transformation, parsing, and transfer between laboratory instruments and enterprise applications.
Exposure to scientific data platforms or cloud-based laboratory integration solutions is preferred.
GxP & Computer System Validation (CSV)
Strong knowledge of GxP regulations and Computer System Validation (CSV).
Hands-on experience preparing and executing validation protocols and test scripts for regulated applications.
Understanding of ALCOA+ data integrity principles, 21 CFR Part 11, and EU Annex 11.
Testing Tools & Methodologies
Experience with test management and defect tracking tools such as HP ALM and Jira.
Familiarity with Agile delivery methodologies, including Scrum and Kanban.
Understanding of functional, integration, regression, and negative testing. Ready to apply for GxP Lab Systems Integration Test Engineer?
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