Principal IT Lab Integration Developer

Role Summary

The Principal IT Lab Integration Developer is responsible for designing, developing, validating, and supporting integrations between laboratory systems, analytical instruments, enterprise platforms (LIMS), and data platforms within a regulated pharmaceutical environment. This role combines application development, system integration, data management, and regulatory compliance within a GMP-regulated laboratory environment.

Responsibilities

• Support the design and implementation of the QC Lab Orchestration Layer, enabling workflow coordination across all Laboratory instruments and middleware.
• Define integration patterns (APIs, event-driven, message queues, file-based where needed).
• Ensure scalability, resilience, and performance of lab integrations.
• Translate QC business processes into orchestrated digital workflows.
• Design and develop integrations between instruments and the Orchestration Layer.
• Build and support API-based, file-based, and message-based integrations (REST, SOAP, SFTP, JSON, XML).
• Provide level 2/3 support for QC Lab Systems.
• Partner with QC Analysts, QA, IT infrastructure and external vendors.
• Develop instrument data capture and automation workflows.
• Configure and support middleware and integration platforms.
• Ensure all integrations comply with GxP, 21 CFR Part 11, and data integrity (ALCOA+) requirements.
• Participate in Computer System Validation (CSV/CSA) activities (IQ/OQ/PQ documentation).
• Perform impact assessments and change control documentation.
• Monitor and troubleshoot integration issues in production environments.
• Collaborate with QC, R&D, Manufacturing, and QA teams.
• Support audits and regulatory inspections.

Qualifications

• Required: BS/BA in Information Technology, Math or related field and 8 years of relevant experience or equivalent combination of education and experience.
• Preferred: Skill in connecting various lab instruments (e.g., liquid handlers, analyzers) to central platforms like LIMS or ELNs to automate data capture and reduce manual transcription.
• Preferred: Knowledge of RESTful APIs, web services, and middleware tools used to bridge communication between the orchestration engine and disparate lab hardware.
• Preferred: Proficiency in languages such as Python or VBA for customizing automated workflows and data parsing.
• Preferred: Ability to understand data formats across different systems, ensure consistent values/naming conventions, and providing the correct data to the authorized locations.