labware lims engineer

Role Summary

We are looking for an experienced LabWare LIMS SME to support global laboratory digital transformation initiatives across Quality Control (QC), Manufacturing, Stability, Environmental Monitoring, and R&D functions. The ideal candidate will possess strong expertise in LabWare LIMS v8, pharmaceutical laboratory processes, system integrations, compliance, validation, and production support.

Key Responsibilities

Functional & Solution Design

• Gather and analyze business requirements from laboratory stakeholders.
• Perform fit-gap analysis and recommend LabWare-based solutions.
• Design and configure laboratory workflows, including sample management, testing, approvals, and electronic signatures.
• Support QC, Stability, Environmental Monitoring, Microbiology, and Manufacturing laboratory processes.

LabWare Configuration & Development

• Configure LabWare objects such as Samples, Tests, Specifications, Products, Materials, Instruments, Users, and Security Roles.
• Develop solutions using LabWare Basic, Event Manager, Triggers, Forms, Smart Screens, and Workflow Rules.
• Implement automations, notifications, calculations, and business rules.

System Integration

• Design and support integrations between LabWare and enterprise systems.
• Integrate with ERP and Quality systems such as SAP ECC/S4HANA, SAP QM, TrackWise, Veeva Quality, or MasterControl.
• Support instrument and CDS integrations including Empower, Chromeleon, OpenLab, HPLC, UPLC, GC, and related laboratory instruments.

Validation, Compliance & Support

• Ensure compliance with GxP, 21 CFR Part 11, Annex 11, ALCOA+, and Data Integrity requirements.
• Support system validation, audit readiness, inspections, and compliance activities.
• Provide L3/L4 production support, incident resolution, root cause analysis, and continuous improvement initiatives.

Mandatory Skills

• 8+ years of experience with LabWare LIMS.

• 5+ years of hands-on LabWare development and configuration experience.

• Strong expertise in:

• LabWare LIMS v8 Configuration

• LabWare Basic Programming

• Security & Role Management

• Workflow Configuration

• Event Management

• Instrument & System Integrations

• Strong SQL knowledge (Oracle preferred).

• Experience with XML, JSON, APIs, and Web Services.

• Knowledge of pharmaceutical laboratory processes and quality systems.

Domain Expertise

• Quality Control Laboratories
• Stability Testing
• Sample Lifecycle Management
• Batch Release Processes
• Analytical Testing Workflows
• GMP/GxP-regulated environments

Preferred Skills

• Experience with SAP ECC/S4HANA, SAP QM, or SAP MDG integrations.
• Exposure to TrackWise, Veeva Quality, or MasterControl.
• Understanding of cloud-based laboratory solutions and digital transformation initiatives.

Compliance Knowledge

• GxP
• FDA 21 CFR Part 11
• EU Annex 11
• Computer System Validation (CSV)

Data Integrity & ALCOA+Role & responsibilities

Preferred candidate profile