Chromatography System Architect designs, implements, and optimizes the hardware-software infrastructure for chromatography data systems (CDS) and analytical instruments. They bridge lab workflows with IT, ensuring scalable cloud/on-prem solutions for peak integration, data management, instrument connectivity, and regulatory compliance (e.g., EPA/FDA/GMP). Experience building software solutions that support regulated laboratory workflows, with specific attention to GxP/GMP requirements is preferred.
Key Responsibilities:
System Design & Architecture: Develops architecture models for CDS, integrating chromatography hardware with software platforms. Defines solution frameworks for full stack components to support laboratory informatics platforms.
Data Processing & Algorithm Implementation: Collaborates with consultants and Developers to oversee algorithms for peak integration, calibration, and quantitation, often leveraging cloud computing and AI/ML.
Instrument & IT Integration: Configures network-connected laboratory instruments (HPLC/UPLC/IC/GC/GCMS/LCMS) with LIMS and data warehouses.
Compliance & Validation: Assists in data integrity and compliance with regulatory standards (e.g., 21 CFR Part 11). Ensures architectural designs and system implementations align with GxP/GMP expectations for regulated laboratory environments.
Technical Leadership: Defines technical specifications, collaborates with software/hardware engineering teams, and troubleshoots complex system issues.
Performance Optimization: Optimizes system performance, scalability, and security.
Define reference architecture, integration patterns, and non-functional requirements.
Setup Development/Beta/Production Environments for successful rollouts
Approve/Get approval for major design decisions and ensure alignment with enterprise roadmaps.
Validate data flows, security posture, and platform choices.
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