IT Specialist III - Application/Data Engineer

Position Summary

The Information Technology Specialist III will provide hands-on software engineering, data integration, testing, deployment, and production support for OCS Data Central and associated OCS tools and services. The position will implement technical solutions defined by the Senior IT Specialist and support reliable day-to-day processing of FDA clinical and nonclinical study data.

Key Responsibilities

• Design, develop, modify, test, install, implement, and support OCS applications, interfaces, data pipelines, databases, and automation.
• Develop and maintain automated processes for study-data ingestion, validation, transformation, quality control, provisioning, and reconciliation.
• Develop automated/manual validation scripts and utilities supporting SDTM, ADaM, SEND, and applicable FDA data-quality/business rules.
• Build and maintain APIs, web services, database integrations, batch processes, and automated workflows connecting OCS/CDER systems.
• Support recurring data loading and processing, application monitoring, troubleshooting, incident resolution, minor bug fixes, and production maintenance.
• Implement exception handling, retry/recovery, audit logging, data lineage, monitoring, and operational alerts.
• Perform unit, integration, regression, system, and deployment testing and maintain reproducible test evidence.
• Troubleshoot data-processing failures, application defects, interface issues, and performance problems through resolution.
• Support Agile development, code/configuration management, releases, deployment validation, and technical documentation.
• Maintain SOPs, runbooks, interface documentation, troubleshooting procedures, and knowledge-transfer artifacts.

Minimum Qualifications

• 5+ years of experience across IT application software development, including design, documentation, development, modification, testing, installation, implementation, and support, as expressly required by the RFTOP.
• Hands-on experience with web/application development, relational databases, SQL, APIs, data integration/ETL, scripting, automated testing, and production support.
• Experience supporting cloud-hosted or enterprise applications and DevSecOps environments.
• Experience with data-quality automation, structured data processing, workflow automation, and troubleshooting preferred.
• Familiarity with FDA/CDISC clinical or nonclinical study-data environments is highly desirable.
• Bachelor's degree in Computer Science, Information Technology, Engineering, or related field preferred.