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Advanced QC Automation Engineer

Dormont Manufacturing Co

The Advanced QC Automation Engineer is the automation cornerstone of Aizon’s Quality Control department. This role designs, builds, and continuously evolves automated testing frameworks that cover both Aizon Execute (iBR) and Aizon Platform (Unify & Predict) — two SaaS solutions deployed in highly regulated GxP pharmaceutical environments.

By transforming manual test scripts into reliable, self‑documenting automated suites that produce human‑readable, audit‑ready evidence, this engineer enables faster release cycles, stronger quality gates, and greater confidence for our pharma and biotech customers worldwide.

Key Responsibilities

  • 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.

Qualifications

Must-have

  • 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.
  • ISTQB Advanced Level certification or equivalent recognized QA/QC certification.
  • Exposure to ISO 27001, SOC 2, or 21 CFR Part 11 compliance requirements in software testing contexts.

The Human We’re Looking For

  • 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.

What We Offer

  • Unique opportunity to join our company as it scales with excellent market traction and huge potential to grow globally.
  • Competitive salary (according to your experience/skills).
  • Equity, bonuses, and generous stock options.
  • Flexible schedule — Intensive Fridays.
  • Language one‑to‑one training courses.
  • Competitive healthcare plans and benefits — Medical & Dental Insurance.
  • Internal training and certifications plan.
  • Flexible remuneration options.
  • Career plan and scheduled salary reviews.
  • Team‑building activities.
  • Top‑notch tech pack — we are Mac lovers!
  • An open and collaborative work environment with a young and dynamic team and a very international culture.
  • An opportunity for personal and professional growth, supported by stellar investors and the exciting challenges that come with joining a company at the start of its growth trajectory.

We are dedicated to maintaining an inclusive workplace in which all employees are treated with respect and are able to contribute meaningfully to society. Our organization brings together professionals from diverse backgrounds, representing more than 28 nationalities, and we take pride in being an equal‑opportunity employer.

Employment decisions are based exclusively on qualifications, merit, and business requirements. Applicants who require assistance or accommodation due to a disability may contact us at Ver el correo electrónico en click.appcast.io.

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Oferta de empleo publicada 3 días atrás
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