The Senior Automation Engineer will develop, maintain, and troubleshoot complex custom automation systems for a biotech stem-cell therapy company. Responsibilities include designing scripted protocols for machine operation, supporting system integration across hardware and software, implementing verification and validation plans, and ensuring compliance with FDA regulations and GxP principles.… The role requires a BS in engineering (Biomedical, Computer, Mechanical, Electrical, or Systems) and minimum 5 years' experience in automation, hardware design, or biotechnology. Key skills include C# proficiency, robotics and motion control systems, machine vision, electronic component integration, and troubleshooting of mission-critical automation equipment.
21-cfr-part-11 jobs in San Diego
The Senior Scientific Platform Engineer will develop and maintain software components, data processing workflows, and platform services that operationalize scientific innovations for clinical studies. The role requires translating research outputs and algorithms into production-grade backend services, APIs, and data pipelines on AWS, while collaborating with Science, Data Science, Product, and Engineering teams.… The ideal candidate has 5+ years building analytics platforms or scientific computing solutions, strong Python proficiency, and experience with cloud-native and serverless architectures. The position demands the ability to understand complex scientific methods and transform them into scalable, validated, maintainable software solutions within a regulated healthcare environment.
The Clinical Data Manager will oversee clinical data management activities for assigned studies, ensuring compliance with protocols, industry standards, and FDA regulations. Responsibilities include managing CRO data management counterparts, developing and maintaining Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient-Reported Outcomes (ePRO) systems, designing Case Report Forms (CRFs), establishing data review strategies, and coordinating data transfers.… The role requires collaboration across Clinical Operations, Clinical Safety, Biostatistics, and external vendors, with a focus on timely database lock and risk identification. Candidates need a bachelor's degree in a medical or scientific field, minimum 2 years of clinical data management experience, proficiency with Microsoft Office Suite, and knowledge of CDISC standards, ICH guidelines, 21 CFR Part 11, and FDA guidelines.