Spclst , Scitara Tester
Core
Integration testing of analytical and ancillary instrument systems to ensure data flows, transformations, and workflows meet GxP and Computer System Assurance (CSA) expectations.
Role type
Instrument & Integration Tester (QA)
Builds
Verified and validated instrument-to-system and system-to-system integrations for laboratory and manufacturing environments.
Domain
Life Sciences / Biopharma / Laboratory Instrumentation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Test design and execution, Defect management, Computer System Assurance (CSA), GxP compliance, Data integrity (21 CFR Part 11, EU Annex 11), API/file-based/OPC UA integration validation, Traceability management, Risk-based testing
Preferred skills
CSQE certification, Experience with Scitara DLX, Familiarity with digital validation systems (Kneat eVal, X-Ray, TOSCA, Robot Framework), FAIR data principles
Technologies
Scitara DLX, Empower, BIOVIA, MODA-EM, LabX, Labware LIMS, OPC UA, API, File-based integrations
Responsibilities
Author and execute test cases/scripts for instrument integrations, Validate data exchange and transformation accuracy, Manage defects and ensure reproducible documentation, Participate in requirements and design reviews, Ensure alignment with CSA and data integrity principles, Identify opportunities for testing efficiency improvements
Seniority
Mid-level, hands-on IC
