Bigfinite Inc.
Report to: QC Lead
Design and own the end-to-end automated test strategy for Aizon Execute (iBR), Aizon Unify, and Aizon Predict, covering functional, regression, integration, and API test layers across both SaaS platforms based on the guidelines defined by the QC Lead
Build and maintain automated test suites using modern frameworks (e.g., Playwright/Selenium for UI, Pytest/RestAssured for API), ensuring broad coverage of all critical GxP workflows and user journeys. The goal is to take advantage of AI in order to develop real human workflows covered by the automated test.
Develop CI/CD-integrated pipelines (Jenkins, GitHub Actions, or equivalent) that automatically trigger and report test execution on every build, providing continuous quality feedback to the Engineering team.
Generate structured, human-readable test evidence reports and execution logs that comply with GMP documentation requirements (CSV / GAMP 5 / 21 CFR Part 11) and are ready for internal and customer regulatory audits.
Design and implement automated data integrity and validation checks for Unify’s data fabric layer, verifying correct ingestion and contextualization of MES, LIMS, ERP, historian, and QMS data.
Automate validation of Aizon Predict’s AI/ML model management workflows, including model deployment, monitoring, and drift-detection test scenarios.
Maintain a comprehensive traceability matrix that links requirements, test cases, and automated evidence artifacts, supporting IQ/OQ/PQ validation packages for customer deliverables.
Collaborate with Product and Engineering teams during sprint planning and backlog grooming to define testable acceptance criteria and embed shift-left quality practices.
Research and evaluate emerging test-automation and AI-assisted testing tools, introducing innovations that increase coverage and reduce execution time.
Mentor junior QC engineers on automation best practices, scalable code quality, and GMP-compliant testing documentation.
4+ years of experience in software QA/testing, with at least 2 years focused on test automation for SaaS or cloud-based applications.
Proficiency in Python and/or JavaScript/TypeScript for writing maintainable, scalable automated test code.
Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related technical field.
Hands-on experience with UI and API test automation frameworks (e.g., Playwright, Selenium, Cypress, Pytest, RestAssured, or equivalent).
Experience integrating automated tests into CI/CD pipelines (Jenkins, GitHub Actions, GitLab CI, or equivalent).
Solid understanding of GxP, CSV (Computer System Validation), or GAMP 5 principles applied to SaaS product testing.
Willing to comply with and follow all regulations required when working in a highly regulated environment, such as ISO standards and GMP regulations.
Demonstrated ability to produce human-readable, audit-ready test evidence and traceability documentation suitable for regulated GxP environments.
Familiarity with test management and defect tracking tools (e.g., Jira/Xray, TestRail, Zephyr, or similar).
Nice-have
Experience testing data platform or data integration solutions (ETL pipelines, data quality validation, historian/LIMS/MES connectivity).
Knowledge of AI/ML model validation approaches, including testing for model outputs, drift detection, and audit trails in GxP settings.
Familiarity with pharmaceutical manufacturing processes and systems (MES, LIMS, DCS, QMS, ERP) relevant to GMP environments.
Experience with performance and load testing tools (k6, Locust, JMeter, or similar) for SaaS application benchmarking.
Exposure to ISO 27001, SOC 2, or 21 CFR Part 11 compliance requirements in software testing contexts.
An automation advocate who instinctively looks at any manual process and asks: “How can we make this self-running, self-documenting, and repeatable?”
A clear communicator who can translate technical test findings into plain language for
product managers, customer success teams, and even pharma customers during regulatory audits.
A collaborative team player who thrives in a small, agile QC team, is comfortable wearing multiple hats, and takes ownership beyond their immediate scope.
Intellectually curious and proactive — always exploring new frameworks, AI-assisted testing techniques, and industry best practices to keep Aizon’s quality standards ahead of the curve.
A meticulous, quality-driven professional who understands that in GMP environments, an untested or undocumented test simply never happened — and takes that responsibility personally.
Someone with a compliance mindset who embraces regulatory rigor not as a constraint, but as a professional standard that protects patients and builds lasting customer trust.