gxp jobs in San Diego

Principal Engineer leading the design, build, and operation of a Microsoft Fabric–based unified data platform (UDP) serving 50+ enterprise source systems across R&D, Commercial, Manufacturing, and Supply Chain. You will architect production-grade data ingestion pipelines, mentor data and analytics engineers, enforce engineering standards and SLAs, manage external implementation partners, and build the semantic layer and governance controls.…See more The role requires 10+ years of data engineering and platform architecture experience, 2+ years of technical leadership in a lakehouse environment, and deep hands-on expertise in Microsoft Fabric (lakehouses, Data Factory, deployment pipelines), PySpark, T-SQL, Python, medallion-architecture design, CI/CD, and data governance tooling—with biopharmaceutical or regulated-industry GxP experience strongly preferred.

Provide IT infrastructure, application, and technical support for laboratory environments in life sciences/pharmaceutical/biotechnology settings. Install, configure, maintain, and troubleshoot laboratory IT systems including LIMS, ELN, LES, CDS applications, laboratory instruments, Windows servers, Active Directory, and networking.…See more Support GxP-regulated environments, system validation, change control, and audit activities while ensuring security, availability, and data integrity.

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.

Sr. Specialist overseeing quality assurance systems, records management, and compliance in a pharmaceutical/biotech GxP-regulated environment.…See more Responsibilities include managing electronic quality systems, processing controlled documents and SOPs, supporting inspections and audits, analyzing quality metrics and dashboards, leading process improvement initiatives, and mentoring junior staff. Requires a bachelor's degree with 4+ years of pharma/biotech QA experience (or master's with 2+), strong knowledge of FDA/ICH/GMP/GLP/GCP regulations, proficiency with QMS and LMS platforms, and demonstrated leadership and analytical capabilities.

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.

Principal Engineer leading the design, build, and operation of an enterprise data platform serving 50+ source systems across R&D, manufacturing, supply chain, and business functions. Responsible for hands-on architecture of medallion-layer pipelines using Microsoft Fabric, technical leadership and mentorship of data engineers, vendor management, data governance implementation, and platform reliability—balancing feature delivery with security, compliance (GxP), and operational excellence in a regulated biopharmaceutical environment.See more

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.

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 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.

Director-level IT Infrastructure role overseeing enterprise virtualization, hybrid cloud operations (Azure/AWS), network infrastructure, and disaster recovery across a regulated pharmaceutical environment. Responsibilities include developing multi-year infrastructure roadmaps, managing budgets and vendor relationships, leading infrastructure teams, ensuring compliance (GxP, SOX, HIPAA), and driving cloud migrations and digital transformation initiatives.…See more Requires 10+ years of progressive infrastructure experience with 4+ years in senior leadership, deep expertise in virtualization platforms (VMware, Nutanix, Hyper-V), Microsoft Active Directory, and cloud architecture.

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 CMMS Administrator will manage computerized maintenance management system operations for a GXP-compliant pharmaceutical/biotech manufacturing environment. Responsibilities include administering maintenance and calibration work requests, overseeing department training programs with GXP tracking, managing service contracts through contract management systems, and reporting facility metrics for trending.…See more The role requires 2+ years of CMMS experience, a BS/BA degree with 2–4 years in regulated pharma/biotech manufacturing (or AA with 3–5 years), and proficiency in MS Office Suite.

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.