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The Copley Consulting Group

LabWare LIMS Config / Intergration

Career Insights for Validation Specialist

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What they do

A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.

$101,424 / year median in California

+8% projected growth

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Job Description

Serves as the LabWare LIMS Configuration Specialist supporting a LabWare 8 upgrade for a US‑based GMP laboratory. Leads a dedicated workstream implementing raw material and commercial product workflows, master data configuration, and system/equipment integration. Translates regulatory, quality, and operational requirements into standardized, compliant LabWare LIMS designs suitable for GMP manufacturing environments Key Responsibilities Lead a focused workstream implementing raw material and commercial product processes within LabWare LIMS 8 Define and manage LabWare build scope across raw material and product master data, test workflows, and laboratory equipment interfaces Configure raw materials, commercial products (including stability), and laboratory equipment using standardized, compliant LabWare design patterns Ensure configuration aligns with approved test methods, product specifications, and sampling plans Apply controlled build practices and normalized templates to maintain consistency, scalability, and compliance Translate regulatory and operational requirements into clear, traceable LabWare LIMS configurations Support validation activities through complete documentation and requirements traceability Configure and maintain instrument interfaces between LabWare 8 and laboratory systems; support parsing script development when appropriate Maintain connectivity and data flow between LabWare and other GMP systems Support stable execution of raw material and equipment workflows in live operations Troubleshoot configuration and integration issues impacting laboratory execution Partner with site teams to ensure configurations are fit for use and operationally sustainable Required Qualifications Hands‑on experience configuring LabWare LIMS (LabWare 8 strongly preferred) Strong background supporting GMP laboratory operations, including raw material testing, commercial product testing, and equipment workflows Demonstrated ability to translate regulatory and quality requirements into compliant LIMS configurations Experience supporting LIMS validation with full requirements traceability Experience integrating LabWare with instrument systems (e.g., Empower, LabX) Strong cross‑functional communication skills in regulated environments Preferred Qualifications Experience supporting LabWare upgrades or major LIMS implementations Experience in biopharmaceutical or pharmaceutical GMP environments Experience supporting inspection readiness activities related to LIMS Deliverables & Success Criteria On‑time completion of LabWare LIMS configurations for raw materials, commercial products, and equipment integration Clear requirements‑to‑configuration‑to‑validation traceability Stable, compliant execution of configured workflows in operations Successful integration between LabWare and laboratory instruments