AI Software Engineer - Life Sciences SaaS

• Design, develop, test, and maintain AI-enabled SaaS applications and services.
• Build and integrate AI/ML capabilities, including generative AI and large language model (LLM) applications, into production software.
• Develop APIs, backend services, data pipelines, and user-facing functionality within a scalable SaaS architecture.
• Work with structured and unstructured scientific and regulatory data to develop intelligent workflows and automation.
• Apply AI to pharmaceutical regulatory and submission-related use cases, including document analysis, content generation, classification, extraction, and quality review.
• Develop solutions that support regulatory submissions and associated documentation, including INDs, NDAs, and BLAs.
• Collaborate with scientists, regulatory professionals, product managers, and software engineers to translate domain requirements into practical software solutions.
• Help evaluate, test, and improve AI models for accuracy, reliability, traceability, and usability in regulated environments.
• Develop automated testing and validation approaches for AI-enabled applications.
• Participate in architecture, code reviews, debugging, deployment, and ongoing product improvement.
• Stay current with emerging AI technologies, software engineering practices, and developments in life sciences and regulatory technology.

We are seeking an AI Software Engineer with 1 3 years of professional experience to join a growing life sciences technology organization. This role is ideal for someone who combines a strong science or life sciences background with hands-on SaaS software development experience and a strong interest in applying artificial intelligence to pharmaceutical and biotechnology workflows. The successful candidate will help design, develop, and enhance AI-powered software solutions that support complex regulatory and scientific processes. The role offers an opportunity to work at the intersection of AI, software engineering, life sciences, and regulatory affairs., * 1 3 years of professional software engineering or SaaS development experience.

• Bachelor’s or Master’s degree in Computer Science, Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or a related scientific/technical discipline.
• Strong programming skills in one or more modern languages such as Python, JavaScript/TypeScript, Java, or C#.
• Experience developing or contributing to SaaS applications, APIs, web services, or cloud-based software.
• Demonstrated understanding of AI/ML concepts, with hands-on experience using AI/ML frameworks, APIs, or LLM-based applications.
• Familiarity with generative AI, LLMs, prompt engineering, RAG, embeddings, or AI agents.
• Strong analytical and problem-solving skills.
• Ability to understand scientific and technical information and translate it into software requirements and solutions.
• Strong written and verbal communication skills.

Highly Preferred

• Familiarity with pharmaceutical regulatory affairs and regulatory submissions, particularly IND, NDA, and BLA processes.
• Experience working with regulatory documents, submission content, clinical or scientific documentation, or pharmaceutical development workflows.
• Exposure to FDA regulations, regulatory submission standards, or GxP environments.
• Experience with cloud platforms such as AWS, Azure, or Google Cloud.
• Experience with relational databases, SQL, REST APIs, Git, CI/CD, and modern software development practices.
• Experience working with document processing, NLP, information extraction, or scientific data.

• Familiarity with pharmaceutical, biotechnology, clinical research, or regulatory technology applications., The ideal candidate is a technically strong early-career engineer who also understands science. You don’t need to be an expert in every area, but you should be comfortable moving between software code, AI technologies, scientific concepts, and regulatory documentation. You are curious, highly analytical, comfortable learning new technologies, and excited about using AI to solve real-world problems in the life sciences. You should enjoy working in a small, entrepreneurial environment where you can take ownership, contribute across the technology stack, and see your work directly influence the product. What You Will Gain

• Hands-on experience building production AI applications in the life sciences.
• Exposure to pharmaceutical regulatory affairs and FDA submission processes.
• Opportunity to work directly with AI/LLM technologies and emerging software architectures.
• Broad experience across SaaS engineering, AI, data, and regulated life sciences.
• Significant responsibility and opportunity for growth within a small, technology-focused organization.

Location: HYBRID 3 days/week in Wilmington, Delaware Experience: 1 3 years Education: Bachelor’s or Master’s degree in a scientific, engineering, computer science, or related technical discipline Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.