Title: LabWare LIMS Configuration Specialist
Location: Thousand Oaks, CA 91320 (Onsite)
Duration: 6+ Months (Possible Extension)
Job Summary
We are seeking an experienced LabWare LIMS Configuration Specialist to support a LabWare 8 upgrade and implementation for a U.S.-based GMP laboratory site.
The consultant will lead a dedicated workstream focused on implementing raw material and commercial product workflows, completing master data configuration, and supporting laboratory equipment and system integrations.
The ideal candidate will have strong hands-on experience configuring LabWare LIMS 8 within a regulated pharmaceutical or biopharmaceutical GMP environment and will be able to translate regulatory, quality, and operational requirements into compliant, standardized LIMS configurations.
Key Responsibilities
Workstream Leadership & Scope Definition
Support and manage a dedicated workstream for implementing raw material and commercial product processes within LabWare LIMS 8.
Define and manage LabWare configuration activities covering:
Raw material and commercial product master data
Test workflows
Laboratory equipment and instrument interfaces
Coordinate closely with Laboratory, Quality, Validation, and IT teams.
LabWare LIMS Configuration
Perform hands-on configuration of raw materials, commercial products, stability workflows, and laboratory equipment in LabWare LIMS.
Configure workflows using standardized and compliant design patterns.
Ensure configurations align with:
Approved test methods
Product specifications
Sampling plans
GMP requirements
Apply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
Requirements Traceability & Validation
Translate regulatory, quality, and operational requirements into standardized LabWare LIMS designs.
Support LIMS validation activities and ensure clear requirements-to-configuration-to-validation traceability.
Prepare and maintain appropriate configuration and validation documentation in accordance with Takeda procedures.
Follow established change control, validation, and data integrity requirements.
Instrument & System Integration
Configure and support interfaces between LabWare 8 and laboratory instruments/systems.
Support integration with laboratory and enterprise GMP systems, including LabX and similar platforms.
Develop or support parsing scripts when required and permitted under established governance and standards.
Troubleshoot connectivity, interface, and data-flow issues between LabWare and connected systems.
Operational Readiness & Support
Support stable execution of raw material, commercial product, and laboratory equipment workflows in live operations.
Troubleshoot LabWare configuration and integration issues that impact laboratory execution.
Partner with site laboratory teams to ensure configurations are fit for intended use and operationally sustainable.
Support project readiness and implementation activities as the LabWare upgrade progresses.
Required Qualifications
Proven hands-on LabWare LIMS configuration experience; LabWare 8 strongly preferred.
Strong experience working with LabWare in GMP laboratory environments.
Experience configuring:
Raw material testing workflows
Commercial product testing workflows
Stability workflows
Laboratory equipment/instrument workflows
Ability to translate regulatory, quality, and operational requirements into compliant LIMS configurations.
Experience supporting LIMS validation and requirements traceability.
Experience integrating LabWare with laboratory instruments and systems, such as:
Empower
LabX
Strong understanding of GMP, data integrity, change control, and validation requirements.
Strong communication and collaboration skills in a regulated environment.
Preferred Qualifications
Experience supporting LabWare upgrades or major LIMS implementations.
Pharmaceutical or biopharmaceutical GMP laboratory experience.
Experience with inspection readiness activities related to LIMS.
Experience with instrument integration and interface troubleshooting.
Experience with LabWare parsing scripts or related integration technologies.
Key Deliverables & Success Criteria
The successful consultant will be expected to deliver:
Completed and compliant LabWare configurations for:
Raw materials
Commercial products
Stability workflows
Laboratory equipment
Clear requirements → configuration → validation traceability.
Successful integration between LabWare and laboratory instruments/systems.
Stable and compliant execution of configured workflows in laboratory operations.
Timely resolution of configuration and integration issues.
Documentation aligned with Takeda's validation, change control, and data integrity requirements.
Work Environment
This role will work closely with Quality, Validation, IT, Laboratory, and project teams.
All work must comply with applicable GMP, data integrity, validation, and change control requirements.
Onsite presence may be required depending on the project phase, laboratory activities, and site requirements.
Key Technical Keywords
LabWare 8 | LabWare LIMS | LIMS Configuration | GMP | Raw Materials | Commercial Products | Stability | Laboratory Equipment | Instrument Integration | LabX | Empower | Master Data | Test Methods | Sampling Plans | Validation | Requirements Traceability | Change Control | Data Integrity | Pharmaceutical | Biopharmaceutical
Benefits:
We offer a competitive compensation package that includes:
• [Pay Rate]: $90 - $95 per [Hour/Year]
o Note: Pay rate will be commensurate with experience.
• Medical for full time employees
• Dental, and Vision Insurance
• Life Insurance, Short-Term Disability, Long-Term Disability, etc.