Job Description

About Us :

Modicus Prime’s mission is to improve the quality of pharmaceutical drug manufacturing and save patient lives by leveraging the power of AI and advanced analytics. Our AI platform solves for the cost, legal, and waste liabilities from product quality failures across pharmaceutical R&D and manufacturing. Modicus Prime is a Johnson & Johnson JLABS company and is venture-backed by Austin-based Silverton Partners along with strategic partnerships with many large corporations including Takeda Pharmaceuticals, Oak Ridge National Laboratory (DOE), eLabNext (Eppendorf), Dotmatics, and PlugandPlay. Modicus Prime was most recently featured in the Wall Street Journal on July 18th, 2024, following our latest investment announcement.

We are now seeking a talented and experienced Pharma QA Automation Engineer to join our testing initiatives and ensure compliance with GxP standards. If you are eager to make an impact in the pharma industry and enjoy rapidly scaling products and teams, consider applying to join our team.

Position Overview and Key Responsibilities :

Work closely with our team to build new features and maintain existing ones for the company’s suite of products. Our products are cloud-based applications that automate various AI/ML services and support our customers in implementing AI/ML in a GxP environment. You will be responsible for the end-to-end testing of software features, including designing scalable testing systems and developing and documenting software testing workflows.

You will collaborate with cross-functional team members, data scientists, and DevOps engineers, to ensure high-quality deliverables that meet business objectives and customer needs. This role requires a proactive approach to problem-solving, attention to detail and software development guidelines, and a passion for innovation in the AI/ML domain to enable its usage in high impact industries. Shaped by the nature of the environment where our software is used, our development team prioritizes best practices in automation to streamline day-to-day workflows and maximize efficiency.

This role is U.S.-based, and visa sponsorship cannot be accommodated at this time.

Basic Qualifications :

• At least 8 years of experience in QA automation, with expertise in designing and implementing robust automated testing frameworks.
• Proficiency in programming with Python and JavaScript for developing and maintaining test automation frameworks..
• Knowledge and experience with the Playwright test automation tool, using both Python and JavaScript for creating scalable automated test scripts.
• Proficiency in creating and managing test plans, test cases, and test reports, aligned with software development guidelines.
• Strong understanding of CI/CD pipelines and integrating automated tests into deployment workflows.
• Solid experience with API testing tools (e.g., Postman, REST Assured) and backend testing.
• Familiarity with performance testing tools (e.g., JMeter, K6) to evaluate system scalability and reliability.
• Strong understanding of software testing methodologies, including functional, integration, and regression testing.
• Ability to write clear, detailed, and effective bug reports and test documentation.
• Knowledge of security testing methodologies, including vulnerability and penetration testing.
• Experience with real-time monitoring and logging tools (e.g., Grafana) for analyzing test results in production environments.
• Strong familiarity with database testing, including writing complex SQL queries and validating data integrity.
• Experience with testing distributed systems and microservices architectures.
• Ability to prioritize testing based on criticality and risk assessment.

Additional Preferred Qualifications:

• Understanding of GxP compliance guidelines as outlined by regulatory bodies like the FDA and EMA.
• Experience with AI/ML in GxP systems and knowledge of their validation challenges.
• Knowledge of 21 CFR Part 11 regulations for electronic records and electronic signatures.
• Experience in computer system validation (CSV), including writing and executing validation protocols (IQ, OQ, PQ).
• Familiarity with the GAMP 5 guidelines for validating computerized systems in regulated environments.
• Experience preparing for and participating in audits by regulatory bodies or internal quality teams.
• Experience automating tests in a way that complies with GxP validation requirements, ensuring reproducibility and auditability.
• Familiarity with biotech or pharmaceutical software, such as LIMS (Laboratory Information Management Systems), MES (Manufacturing Execution Systems), or eQMS (electronic Quality Management Systems).

Additional Information:

1. Location: Austin preferred

2. Job Type: Full-time

3. Pay (with equity): $90k - $110k depending on skills and/or qualifications

What We Offer :

• Enjoy the benefits of a flexible work schedule within a remote working environment, while also having the opportunity to connect with your colleagues through regular in-person meetings in Austin, including team luncheons.
• The chance to work on groundbreaking projects that are transforming the pharmaceutical industry.
• A supportive and collaborative team culture, with ample opportunities for professional growth and development, including conference speaking opportunities.

Equal Opportunity Employer Statement:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.

To Apply :

Please submit your CV and any relevant portfolio or project examples to info@modicusprime.com . We look forward to hearing from you and exploring how your ambitions and expertise can help shape the future of Modicus Prime and the pharmaceutical industry at large.

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