LIMS Business Analyst: GMP, UAT & Lab Workflows

ALTEN Technology USA; Waltham (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

ALTEN Technology USA seeks a detail-oriented LIMS Business Analyst to support deployment of a new laboratory information management system in an Analytical Sciences setting. You will bridge lab operations and digital platforms, translating workflows into structured system solutions while ensuring compliance with FDA cGMP and 21 CFR Part 11.

The role emphasizes collaboration with scientists and cross-functional teams, with emphasis on validation, configuration, and documentation to support system

Qualifications

• Experience as a Business Analyst, preferably within LIMS, laboratory systems, or scientific environments.
• Strong understanding of laboratory workflows, analytical methods, and data processes.
• Experience working in GMP-regulated environments with knowledge of FDA cGMP and 21 CFR Part 11 requirements.
• Hands-on experience with system configuration, UAT, and requirements gathering.

Responsibilities

• Partner with analytical scientists and subject matter experts to understand and document laboratory methods and workflows.
• Translate scientific processes into structured method templates using a low-code platform
• Configure workflows, methods, and system logic within the LIMS environment (no coding required)
• Develop, execute, and document user acceptance testing (UAT) to ensure system functionality meets requirements
• Identify and support resolution of system gaps between current processes and the new platform
• Assist with configuring instrument connectivity and data capture across laboratory systems
• Ensure all system configurations and processes comply with FDA cGMP and data integrity standards (including 21 CFR Part 11)
• Collaborate with cross-functional teams to align system standards, documentation, and best practices
• Contribute to knowledge transfer efforts and support documentation for system readiness and ongoing use

Skills

Business analysis

LIMS experience

GMP/regulatory knowledge

UAT

System configuration

Job description

ALTEN Technology USA seeks a detail-oriented LIMS Business Analyst to support deployment of a new laboratory information management system in an Analytical Sciences setting. You will bridge lab operations and digital platforms, translating workflows into structured system solutions while ensuring compliance with FDA cGMP and 21 CFR Part 11.

The role emphasizes collaboration with scientists and cross-functional teams, with emphasis on validation, configuration, and documentation to support system