LabWare LIMS Configuration & Integration Specialist (LIMS Basic, CDS & GxP Validation)

SGS Consulting; Thousand Oaks (CA); On-site; USD 96,000 - 165,000; Full time

Job summary

SGS Consulting is seeking an experienced LabWare LIMS Configuration & Integration Specialist to lead design, configuration, integration, and CSV/validation activities in a compliant laboratory environment. The role bridges lab operations, quality, and IT, translating GxP requirements into technical workflows and secure system interfaces.

Responsibilities include configuring LIMS, building integrations with SAP ERP, ELN, and SDMS, and ensuring data integrity per FDA 21 CFR Part 11 and ISO 17025.

Qualifications

• Bachelor’s degree in a scientific/technical discipline.
• 4+ years of LabWare LIMS configuration, administration, and integration in a regulated lab environment.
• Proficient in writing LIMS Basic code for custom calculations and dialogs.
• Experience with REST/SOAP APIs, SQL interfaces, serial communication, and XML/JSON/CSV parsers.
• Hands-on experience integrating CDS systems and benchtop instruments with LabWare.

Responsibilities

• Configure LabWare LIMS master data: Sample Types, Analysis Specifications, Test Lists, UOM, Sampling Points.
• Write and optimize LIMS Basic scripts for dynamic business logic and automated events.
• Design visual workflows, UIs, templates, and lifecycle states (Logged → Sampled → Tested → Reviewed → Released).
• Maintain RBAC, user groups, and electronic signatures.

Skills

LIMS Basic scripting

REST/SOAP APIs

System integration

Data parsing (XML/JSON/CSV)

Education

Bachelor’s degree in Computer Science, Bioinformatics, Chemistry, Biotechnology, or related field

Tools

LabWare LIMS

Oracle / SQL Server

PL/SQL scripting

SAP QM integration

LabWare ELN

Job description

Job Title: LabWare LIMS Configuration & Integration Specialist

Job Location: Thousand Oaks, CA 91320 (Onsite)

Job Duration: 06 – 12 Months Contract + (Highest possibilities of extension)

Role Summary:

We are seeking an experienced LabWare LIMS Configuration & Integration Specialist to lead the design, configuration, integration, and validation of our LabWare LIMS environment. In this role, you will bridge the gap between laboratory operations, quality management, and IT infrastructure. You will be responsible for translating business and GxP requirements into technical workflows, configuring core LabWare modules and LIMS Basic scripts, and establishing secure, automated integrations with laboratory instrumentation (CDS, balances, pH meters) and enterprise platforms (SAP ERP, ELN, SDMS).

Key Responsibilities:

1. LIMS System Configuration & Workflow Development

• Configure and maintain LabWare LIMS master data, including Sample Types, Analysis Specifications, Test Lists, Units of Measure (UOM), and Sampling Points.
• Write, test, and optimize LIMS Basic scripts to automate dynamic business logic, conditional sample routing, complex result calculations, and trigger events.
• Design and implement visual workflows, user interfaces, dynamic data entry templates, and lifecycle states (e.g., Logged → Sampled → Tested → Reviewed → Released).
• Maintain Role-Based Access Control (RBAC), user groups, security configurations, and electronic signature hierarchies.

2. Instrument & System Integrations

• Integrate simple laboratory instruments (balances, pH meters, titrators) via RS-232, serial-to-ethernet, and TCP/IP using LabWare LabStation / Instrument Interface modules.
• Interface complex systems—such as Chromatography Data Systems (Waters Empower, Thermo Chromeleon, Agilent OpenLab) and mass spectrometers—using database interfaces, REST/SOAP APIs, and automated file parsing (CSV, XML, JSON).
• Build and support enterprise interfaces connecting LabWare LIMS with SAP ERP (batch release, inspection lots, usage decisions), Electronic Lab Notebooks (ELN), and Scientific Data Management Systems (SDMS).
• Configure Single Sign-On (SSO) and central authentication via LDAP / Active Directory / SAML 2.0.

3. Compliance, Validation & Data Integrity

• Ensure all system configurations and integrations adhere to GxP standards, FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles.
• Author and execute Computer System Validation (CSV) lifecycle deliverables following GAMP 5 principles, including User Requirements Specifications (URS), Functional Specifications (FS), IQ/OQ/PQ scripts, and Traceability Matrices.
• Manage audit trail configurations and ensure strict compliance for electronic signatures and records.

4. Technical Support, Maintenance & Governance

• Troubleshoot complex technical issues, system errors, and integration failures between LIMS, CDS, and ERP environments.
• Lead minor and major system upgrades, patch installations, and patch regression testing.
• Develop standard operating procedures (SOPs), system administration guides, and technical training materials for end users and super users.

Qualifications & Skills:

Required Experience & Technical Expertise:

• Education: Bachelor’s degree in Computer Science, Bioinformatics, Chemistry, Biotechnology, or a related scientific/technical discipline.
• Experience: 4+ years of hands‑on experience in LabWare LIMS configuration, administration, and integration within a regulated laboratory environment (Pharmaceutical, Biotech, Medical Device, or Testing Laboratory).
• LIMS Basic Scripting: Proficient in writing LIMS Basic code for custom calculations, dialogs, and event‑driven automation.
• Integration Protocols: Demonstrated experience with REST/SOAP APIs, SQL/database‑level interfaces, serial communication, and file parsers (XML, JSON, CSV).
• Instrument Connectivity: Hands‑on experience integrating CDS systems (Empower, Chromeleon, OpenLab) and benchtop instruments with LabWare.

Regulatory & Quality Compliance:

• Deep understanding of FDA 21 CFR Part 11, EU Annex 11, ISO 17025, and GxP standards.
• Strong working knowledge of GAMP 5 methodology and full Computer System Validation (CSV) life cycles.

Preferred / Bonus Qualifications:

• LabWare LIMS Certified Administrator or Master Developer credentials.
• Hands‑on experience with SAP Quality Management (QM) integration.
• Experience with LabWare ELN module implementation.
• Familiarity with database management (Oracle, MS SQL Server) and PL/SQL scripting.