LabVantage LIMS Instrument Integration SME / Lead Validation Engineer

Introduction:

We are seeking an experienced LabVantage LIMS Instrument Integration SME to support the design, configuration, integration, and lifecycle management of LabVantage LIMS within a regulated GxP environment. This role will serve as a technical subject matter expert responsible for integrating laboratory instruments, instrument control systems, and enterprise applications while ensuring compliance with security, validation, and data integrity standards. The ideal candidate will collaborate with internal teams, vendors, and business stakeholders to deliver secure, scalable, and compliant laboratory system solutions.

Responsibilities:

• Design, develop, configure, and support LabVantage LIMS integrations with laboratory instruments, instrument control systems, and enterprise applications
• Collaborate with technical teams, business stakeholders, vendors, and project teams to deliver compliant and scalable LIMS solutions
• Ensure systems, integrations, and related services are installed, configured, tested, and maintained in accordance with GxP, data integrity, and company standards
• Author and maintain technical documentation including integration specifications, security configurations, user roles, data migration strategies, and system customizations
• Support system lifecycle activities including installation, configuration, maintenance, troubleshooting, change management, and ongoing operational support
• Ensure solutions align with enterprise security architecture, cybersecurity standards, and regulatory compliance requirements including 21 CFR Part 11
• Perform technical assessments, risk evaluations, and defect resolution activities to ensure solutions meet business and compliance requirements prior to formal testing
• Manage and support version-controlled custom code, interfaces, and configuration artifacts using approved source code management tools

Requirements:

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, or related technical discipline
• 5+ years of experience supporting LabVantage LIMS within regulated pharmaceutical, biotechnology, or laboratory environments
• Strong experience integrating LIMS platforms with laboratory instruments and instrument control systems
• Experience with LabVantage instrument integration frameworks and LabVantage configuration tools
• Hands-on experience with system interfaces, data mapping, and integration technologies such as APIs, file-based integrations, middleware, or web services
• Solid understanding of GxP regulations, CSV principles, data integrity requirements, and 21 CFR Part 11 compliance
• Experience authoring and maintaining SDLC/SLC documentation and technical system documentation
• Knowledge of security concepts including role-based access, system hardening, secure data transmission, and segregation of duties
• Experience supporting change management, incident management, and system lifecycle activities in regulated environments
• Familiarity with laboratory instruments such as HPLC, balances, spectrometers, Empower, Chromeleon, or similar systems
• Strong troubleshooting, analytical, and problem-solving skills
• Excellent communication and cross-functional collaboration abilities