Labs Systems Engineer

Role Overview

This role is for TEMAIL_ADDRESS MQ, responsible for driving, delivering and maintaining MODA and other applications that support laboratory execution and operations across the Manufacturing Quality organization. This role will play a key supporting role within the Global Lab organization by assisting in the implementation, integration, configuration, and support of laboratory systems-primarily Environmental monitoring system - MODA-under the supervision of senior team members.

This role focuses on supporting system operations, integrations, and validation activities, while enabling automation and digital initiatives that improve laboratory efficiency and data integrity.

Key Responsibilities

• Drive the configuration, deployment, maintenance, and operations of MODA Environmental Monitoring systems across Manufacturing Quality laboratories.
• Configure, maintain, and troubleshoot integrations between MODA and laboratory, manufacturing, and enterprise platforms including LabVantage LIMS, Empower CDS, SAP, MES platforms (PMX, PharmaSuite, Syncade), and middleware solutions.
• Develops supports data interfaces, APIs, message-based integrations, and automated workflows to enable compliant sample lifecycle management, environmental monitoring, and results reporting.
• Assist in configuring and maintaining MODA system settings, user access, workflows, monitoring plans, sampling schedules, work item mappings, and data management processes.
• Collaborate with Quality, Laboratory Operations, Manufacturing, Engineering, vendors, and IT teams to support reliable and compliant laboratory and environmental monitoring operations.
• Execute integration of laboratory instruments, monitoring devices, data acquisition systems, and related informatics platforms with MODA and connected systems.
• Drive integration testing, interface validation, deployment, and release activities, ensuring successful implementation of new capabilities and enhancements.
• Contribute to the preparation and maintenance of SOPs, work instructions, system design documents, interface specifications, validation records, and knowledge management artifacts.
• Analyze, triage, troubleshoot, and resolve application, integration, and data-related incidents, service requests, and system issues using tools such as ServiceNow, JIRA, and ALM.
• Develop and execution of MODA Test scripts and IVI execution
• Developing and maintaining validation documents writing (e.g. validation artifacts, SOP, IVI, Test Scripts, etc.)
• Support CSV/CSA validation activities, including requirements traceability, risk assessments, protocol execution (IQ/OQ/PQ).
• Support CAPA, deviation, audit, and change management activities by investigating issues, documenting root causes, implementing corrective actions, and maintaining closure evidence.
• Monitor system and interface performance, identify improvement opportunities, and support automation and digital initiatives that enhance laboratory efficiency, data integrity, and regulatory compliance.

Automation Digital Integration

• Drive workflow automation and digitalization initiatives within MODA to improve operational efficiency, data integrity, and regulatory compliance.
• Develop and execute reporting, analytics, and data visualization capabilities to enable trend analysis, compliance monitoring, and business insights.
• Evaluate and implement integration and automation solutions leveraging APIs, middleware, and enterprise platforms to enhance system interoperability and user experience.

Governance, Validation Compliance

• Implement validation including writing and running test scripts, protocols, and maintaining all supporting validation documentation.
• Ensure all activities are performed and documented in strict compliance with GMP regulations, including 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles.
• Support CAPA management for MODA system-related incidents, ensuring detailed documentation.
• Maintain GMP/GxP/CSV compliance documentation including build specs, configuration specs, and SOPs.
• Team representation in change control activities and periodic system review processes.

Leadership Collaboration

• Work with senior analysts, lab teams, QA, and IT SMEs to support day-to-day operations of MODA-EM system.
• Follow established standards, templates, and procedures defined global governance frameworks.
• Develop Lab system knowledge base through documentation updates, knowledge articles, and SOP revisions.

What You Should Bring

• Good experience with MODA Environmental Monitoring systems, including system administration, integration, configuration, deployment, support, upgrades and lifecycle management.
• Experience supporting environmental monitoring workflows, including viable and non-viable monitoring, personnel monitoring, utilities monitoring, sample scheduling, incubation, trending, investigations, and reporting activities.
• Knowledge of MODA IT architecture (servers, interfaces, log files, etc.)
• Strong understanding of GMP, GxP, 21 CFR Part 11, Annex 11, CSV/CSA, and ALCOA+ principles within regulated pharmaceutical laboratory and manufacturing environments.
• Experience configuring, supporting, or troubleshooting integrations between MODA and laboratory, manufacturing, or enterprise systems such as LabVantage LIMS, Empower CDS, SAP, MES platforms (PMX, PharmaSuite, Syncade), and middleware solutions.
• Knowledge of system interfaces, APIs, middleware technologies, data flows, and integration concepts used to support automated laboratory and environmental monitoring processes.
• Experience supporting validation and compliance activities, including risk assessments, traceability, protocol execution, defect management, and validation documentation.
• Ability to analyze, triage, troubleshoot, and resolve application, integration, and data-related issues using tools such as ServiceNow, JIRA, ALM, or equivalent platforms.
• Working knowledge of SQL, databases, reporting tools, and data analytics platforms to support troubleshooting, reporting, and operational insights.
• Experience supporting laboratory instruments, monitoring devices, and data acquisition systems in regulated environments.
• Strong analytical, communication, stakeholder management, and problem-solving skills with the ability to collaborate effectively across Quality, Manufacturing, Laboratory Operations, Engineering, and IT organizations.
• Exposure to digital transformation, workflow automation, data integration, reporting, dashboarding

Disclaimer: This job posting and location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.