Senior Engineer I, Digital Lab Systems

Role Summary

Senior Engineer I, Digital Lab Systems at Moderna. The role supports the delivery and administration of laboratory systems, assists in configuration and deployment, and participates in generating and maintaining procedures. Activity includes authoring and executing test protocols.

Responsibilities

• Administer, configure, and maintain LIMS, Scitara DLX, LabX, Hamilton, Chromeleon, and LES systems, ensuring seamless connectivity and compliant data flow between instruments and enterprise platforms.
• Design, build, and deploy Scitara DLX integration workflows to automate data exchange between analytical instruments, middleware, and LIMS, ensuring accuracy, traceability, and GxP compliance.
• Develop and maintain Scitara pipeline configurations and function transforms to standardize instrument data, implement business rules, and enable automated reporting and audit trail generation.
• Conduct root-cause analysis and troubleshooting for interface and workflow issues across Scitara, LIMS, and instrument control systems, applying monitoring and diagnostic tools to ensure high system uptime.
• Perform technical assessments, testing, and qualification of new instrument integrations, ensuring compatibility with existing Scitara and LIMS architecture.
• Author and execute system validation documentation (URS, FRS, DS, IQ/OQ/PQ) in alignment with computerized system validation (CSV) and 21 CFR Part 11 requirements.
• Develop, optimize, and support custom JavaScript scripts for automated data transformation, parsing, and validation across integration layers involving LV_Data, LabX results, and Scitara workflows.
• Implement error handling, exception tracking, and data integrity checks using JavaScript to ensure reliable bidirectional communication between systems.
• Build reusable, modular code components to streamline integration logic and enhance scalability for future instrument onboarding.
• Collaborate with laboratory users and IT to analyze workflow requirements, convert functional needs into executable logic, and deploy validated solutions within Scitara DLX.
• Support change management, incident resolution, and performance optimization for lab informatics systems, ensuring minimal downtime and continuous improvement.
• Maintain version control, technical documentation, and code reviews to enforce software quality standards and ensure compliance with internal governance.
• Provide technical support and training to end users for issue resolution, workflow execution, and best practices in digital lab operations.
• Participate in periodic system upgrades, patch validation, and regression testing to ensure sustained compatibility and regulatory compliance.

Qualifications

• Required: A bachelor’s degree in science, Technology, or another relevant discipline.
• Required: Over 10 years of industry experience implementing, integrating, and maintaining laboratory informatics systems within GxP-regulated environments.
• Required: Hands-on experience in Scitara DLX, LIMS, Hamilton, SoftMax, LabX, Chromeleon CDS, and system-to-system integrations with LIMS.
• Required: Strong coding and scripting experience in JavaScript, Python, PowerShell, and SQL, with expertise in automation scripts, data transformation logic, and integration workflows for lab systems.
• Required: Proven ability to design, validate, and deploy digital lab solutions that enhance automation, data integrity, and process efficiency across analytical and QC operations.

Skills

• Lab informatics systems integration
• JavaScript, Python, PowerShell, SQL scripting
• System validation and regulatory compliance (CSV, 21 CFR Part 11)
• Data transformation and workflow automation
• Problem-solving and root-cause analysis

Education

• Bachelor’s degree in science, technology, or related field