21-cfr-part-11 jobs in San Diego

Enterprise Architect Director responsible for defining strategic architecture direction across core enterprise platforms (ERP, CRM, PLM, SCM, quality, laboratory, financial systems) and establishing enterprise-wide integration, API, data, cloud, security, and AI architecture standards. The role requires 12+ years of progressive IT experience with 8+ years in enterprise architecture, strong expertise in integration patterns, modern data platforms, public cloud (AWS/Azure), AI/generative AI, and proven leadership on complex portfolio rationalization and M&A programs.…See more This position influences executive leadership on technology strategy, manages architecture practice budgets and resources, and ensures compliance with GxP, 21 CFR Part 11, and GAMP 5 requirements.

Senior Automation Engineer supporting the development, maintenance, and operation of complex custom automation systems in a biotech environment. Responsibilities include understanding system requirements, developing scripted protocols, supporting system integration across hardware and software, troubleshooting failures, and ensuring compliance with FDA regulations and GxP principles.…See more The role requires proficiency in C#, experience with robotics, motion control, machine vision, and strong problem-solving skills to maintain system uptime in a regulated biotech setting.

Senior software engineer role building autonomous cell-therapy manufacturing instrument software in a regulated environment. Responsibilities span instrument control software architecture, firmware-hardware integration, data pipeline management, CI/CD and SDLC practices, and regulatory documentation.…See more Requires 7+ years developing software for instruments, medical devices, or laboratory automation under regulated lifecycles, with strong C++, Rust, or Python, closed-loop control experience, state-machine architectures, and a safety-critical mindset.

Senior Automation Engineer responsible for developing, maintaining, and operating complex custom automation systems in a biotech stem-cell therapy environment. The role requires designing scripted protocols, integrating hardware and software components, troubleshooting system failures, and ensuring compliance with FDA regulations and GxP principles.…See more Requires 5+ years in hardware design, automation, or biotech; proficiency in C#; and hands-on experience with robotics, motion control, sensors, and machine vision systems.

The Senior Automation Engineer will develop, maintain, and troubleshoot complex custom automation systems for biotech applications, with a focus on hardware–software integration and regulatory compliance. Responsibilities include writing operational protocols, performing system integration, conducting verification and validation testing, and collaborating across cross-functional teams.…See more The role requires a strong foundation in automation engineering principles, C# proficiency, hands-on experience with robotics, motion control, sensors, and machine vision, plus familiarity with FDA regulations (21 CFR Parts 11, 210, 211, 820) and GxP principles.

Support Computer System Validation (CSV) activities for GxP-regulated pharmaceutical and medical device systems, including validation planning, test execution, documentation, and compliance verification against FDA regulations and 21 CFR Part 11. Execute validation test scripts, document results and deviations, conduct impact and risk assessments, and collaborate with cross-functional teams to ensure systems meet regulatory and data integrity requirements.…See more Maintain validation records, support change control and CAPA activities, and identify compliance gaps in regulated computerized environments.

The Clinical Data Manager will oversee data management activities for clinical trials, ensuring compliance with protocols, industry standards, and regulations. Responsibilities include managing Case Report Forms (CRF), Electronic Data Capture (EDC) systems, data review strategies, database lock coordination, and cross-functional collaboration with Clinical Operations, Biostatistics, CROs, and vendors.…See more The role requires 2+ years of clinical data management experience, a bachelor's degree in a medical or scientific field, and proficiency with clinical data entry systems, CDISC standards, ICH guidelines, and FDA regulations.

This is a senior full-stack engineer role responsible for architecting and building internal platforms and cloud infrastructure that serve operations, finance, lab, and external customers. The engineer will design data models and APIs connecting lab systems, business software (NetSuite, ATS, CRM), and internal dashboards; build robust cloud infrastructure managing provisioning, cost, reliability, and security; and set technical direction on architecture, code quality, CI/CD, and observability across a growing engineering org.…See more The role requires 10+ years of full-stack production experience, deep hands-on cloud infrastructure knowledge, modern frontend (React) and backend skills, and ability to work directly with non-engineering stakeholders to translate ambiguous business requirements into shipped software. Over time, the engineer will build and mentor a team.

Staff Software Engineer to own end-to-end LIMS (Laboratory Information Management System) implementation for a clinical/molecular diagnostics lab, connecting sample tracking to lab automation and instrumentation. Responsibilities include building the LIMS platform, creating integrations between LIMS and lab devices, modeling complex sample preparation and assay execution data chains, and ensuring compliance with 21 CFR Part 11.…See more Requires 7+ years of hands-on LIMS experience in clinical or molecular diagnostics, deep knowledge of sample-tracking data models for high-throughput workflows, full-stack programming across UI/APIs/backend, and regulated-environment expertise (21 CFR Part 11, ISO standards, CAP/CLIA). This is a hands-on technical leadership role requiring strong communication between lab scientists, automation engineers, and software teams.

Staff Data Engineer at Illumina seeking a senior individual contributor with 10+ years building and scaling data products on Databricks and Snowflake. The role spans end-to-end ownership of data pipelines across Supply Chain, Manufacturing, and Quality domains, requiring advanced Python, SQL, and data modeling skills with hands-on expertise in Spark, Delta Lake, dbt, and distributed systems design.…See more Responsibilities include designing medallion-architecture data products, embedding governance and data quality, adopting AI in analytics workflows, and mentoring a global engineering team. The candidate will set technical standards, lead architecture decisions, and communicate trade-offs across business, AI, and platform stakeholders.

Senior Systems Engineer responsible for planning and implementing security patches across enterprise Linux and Windows server environments in AWS, Azure, and hybrid infrastructure. Design and operate automation platforms (AWS Systems Manager, Ansible, SCCM/Intune) to scale vulnerability management and remediation across cloud and on-premises fleets.…See more Partner with security, infrastructure, network, and compliance teams on patch testing, deployment sequencing, rollback procedures, and audit-ready documentation in a regulated (GxP/SOX/21 CFR Part 11) environment.

Senior Manager-level ERP architect responsible for end-to-end delivery of Dynamics 365 Finance & Operations across finance workstreams (AP, AR, Fixed Assets, Project Accounting, Cost Management, Procurement). Leads team delivery, owns process improvement and compliance (SOX, 21 CFR Part 11), and serves as primary IT liaison to Finance executives, translating business requirements into functional solutions.…See more Brings 10+ years of hands-on D365 F&O expertise and capability to architect integrations, Power BI reporting, and vendor partnerships independently.

Develop and execute comprehensive automated test plans, test cases, and regression suites for genomics and bioinformatics software applications. Perform functional, integration, regression, and data-validation testing; validate application behavior against genomics concepts (sequencing data, variant calling, sample traceability); and collaborate with wet lab and dry lab teams to translate laboratory workflows into effective test scenarios.…See more Integrate automated tests into CI/CD pipelines, maintain test data, and partner with engineering and product teams on root-cause analysis and quality issue resolution. Requires 3+ years of QA/test automation experience, strong Python skills, hands-on knowledge of genomics fundamentals, and demonstrated experience testing LIMS platforms and life sciences software.

Senior Automation Engineer supporting development, maintenance, and operation of complex custom automation systems in a biotech environment. Responsibilities include understanding system requirements, developing scripted protocols, integrating hardware and software components, troubleshooting failures, and ensuring compliance with FDA regulations and GxP principles.…See more Requires 5+ years in hardware design, automation, or biotech, with proficiency in C#, robotics, motion control, machine vision, and electronic systems integration.

Senior Automation Engineer at a biotech firm developing autologous stem-cell therapies. Responsible for developing, maintaining, and troubleshooting complex custom automation systems, including scripted protocols, hardware-software integration, and verification/validation testing.…See more Requires 5+ years in hardware design, automation, or biotech, with strong C# software integration skills, robotics and motion control expertise, and knowledge of FDA regulations (21 CFR 11, 210, 211, 820) and GxP principles.

The Senior Automation Engineer will develop, maintain, and troubleshoot complex custom automation systems in a biotech setting, working with hardware (robotics, motion platforms, sensors, machine vision) and software (C# codebases). Responsibilities include creating operational protocols, supporting system integration, developing verification and validation plans, and ensuring compliance with FDA regulations (21 CFR Parts 11, 210, 211, 820) and GxP principles.…See more The role requires 5+ years in hardware design, automation, or biotechnology, with strong problem-solving skills and the ability to collaborate across cross-functional teams.

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.…See more 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.…See more 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.