About Us

Modicus Prime is improving the quality of pharmaceutical drug manufacturing and saving patient lives by leveraging the power of compliant AI and advanced analytics. Modicus Prime is a Johnson & Johnson JLABS company and venture-backed by Austin-based Silverton Partners along with strategic partnerships at several large corporations including Takeda Pharmaceuticals, Oak Ridge National Laboratory (DOE), eLabNext (Eppendorf), Dotmatics, and PlugandPlay. Modicus Prime has been featured in the Wall Street Journal and BioProcess International, and the CEO is co-author of the pharmaceutical industry's ISPE AI Guide (2025).

We are now seeking an AI & Data Automation Validation expert to join our company. If you are eager to impact the AI/ML integration in the pharmaceutical industry and enjoy rapidly scaling products and teams, consider applying to join our company.

Position Overview and Key Responsibilities

Responsible for evaluating the technical suitability, risks, and limitations of AI models and AI-enabled products used in regulated GxP environments, with a primary focus on automating compliance. This role assesses model origin, lineage, behavior, change characteristics, security, deployments, monitoring, and release lifecycles readiness to support risk-based adoption and ongoing use.

In addition, this role contributes hands-on to internal AI and software development efforts by testing products, ensuring compliant automation, and supporting engineering teams as needed. Approximately 60% of the role is focused on AI technical assurance activities, with the remaining effort dedicated to direct technical contribution to internal AI-enabled products and systems.

The role works closely with Quality, Compliance, Engineering, and IT Security.

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

Key Qualifications

• Evaluate and document AI model origin, derivation, dependencies, versioning, and change behavior for externally supplied AI models and AI-enabled products.
• Familiar with software release practices and modern tools such as Github releases, server containerization, python software packaging, and Jira reporting.
• Assess high-level training approaches and data characteristics, including disclosed limitations, biases, and data governance practices, without requiring access to proprietary datasets.
• Evaluate model behavior, known failure modes, performance in the intended context of use, reproducibility, and limitations, including stratified performance where applicable.
• Assess explainability, human oversight models, and human factors risks relevant to appropriate use and reliance.
• Evaluate AI security and abuse-resistance controls, including access management, logging, monitoring, and susceptibility to AI-specific threats.
• Assess integration and operational fit, including preprocessing and post-processing controls, scalability, performance, and cost predictability.
• Evaluate readiness for monitoring, drift detection, traceability, artifact retention, and model retirement to support audits and investigations
• Document technical assessment conclusions and communicate identified risks and limitations to VP of GxP Quality and Compliance for inclusion in overall risk assessments.
• Maintain current knowledge of AI technical risk areas, development practices, and industry best practices relevant to regulated use.
• Other duties as assigned as needed.

Basic Qualifications

Bachelor’s degree in Computational Sciences, Engineering, Information Systems, or a related technical field, or equivalent combination of education and relevant professional experience.

Required Experience

• Minimum of three (3) years of experience assessing, developing, testing, or supporting AI-enabled or software systems in regulated, safety-critical, or high-risk environments, with a demonstrated ability to evaluate technical risk, document findings, and support audit-ready decision-making.
• Familiarity with version control and release management systems, such as Github, Github Actions or equivalent
• Experience with project management tracking and reporting software, such as Jira.
• Knowledge of text-based utilities such as bash.
• Hands-on experience contributing to software, AI, or data-driven systems through coding, testing, or technical problem-solving.
• Understanding of AI model lifecycle concepts, including training approaches, inference, versioning, monitoring, drift, and retirement.
• Ability to assess supplier and internal technical documentation without access to proprietary algorithms or training data.
• Working knowledge of key AI risk domains, including bias, robustness, explainability, security, and human oversight.
• Strong analytical, documentation, and communication skills, with the ability to produce clear, audit-defensible technical assessments.
• Ability to work independently, manage multiple priorities, and contribute effectively across assurance and development activities.

What Success Looks Like

• Clear, defensible technical assessments that support risk-based adoption of AI vendors and products.
• Effective documentation and communication around software releases.
• Well-understood model lineage, dependencies, and change behavior suitable for regulatory scrutiny.
• Early identification and communication of AI technical risks and limitations.
• High-quality technical contributions that support reliable, testable, and compliant AI-enabled products.
• Confidence in the organization’s ability to both evaluate and execute AI technologies in regulated use.

Additional Information

1. Location: Austin preferred
2. Job Type: Full-time
3. Pay (with equity): Salary/equity ratio dependent on candidate preferences, 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 lead groundbreaking AI initiatives that are transforming the pharmaceutical industry.
• A supportive and collaborative team culture, with ample opportunities for professional growth and development, including conference speaking opportunities.
• Comprehensive medical, dental, and vision coverage, along with a 401(k) retirement plan.

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 materials 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.