5-7 years of LabWare LIMS configuration experience, with a preference for LabWare 8
In-depth knowledge of GMP laboratory operations, specifically in raw materials and commercial products
Proven ability to convert regulatory and quality requirements into standardized LabWare designs
Experience in supporting LIMS validation with comprehensive requirements traceability
Familiarity with laboratory instrument systems like Empower and LabX
Strong communication skills across various functions in regulated environments
Experience with LabWare upgrades or significant LIMS implementations
Responsibilities
Lead the workstream for LabWare 8 upgrade
Support implementation of raw material and commercial product workflows
Define and oversee LabWare configurations
Manage master data for raw materials and commercial products
Test and validate workflow configurations
Configure instrument interfaces between LabWare and other laboratory systems
Ensure operational readiness and troubleshoot configuration issues
Benefits
Collaborative work environment with opportunities to engage with cross-functional teams
Onsite presence may be required based on project phase, offering direct interaction with various departments
Alignment with Takeda's commitment to quality and regulatory adherence
Contribute to meaningful projects that impact laboratory operations in the biopharmaceutical field
Full Job Description
Job Description:
LabWare LIMS Configuration Specialist to support the LabWare 8 upgrade for a US based GMP laboratory site. This role will lead a dedicated workstream focused on implementing raw material and commercial product workflows, completing master data configuration, and finalizing integration with laboratory equipment and enterprise GMP systems.
The successful candidate will translate regulatory, quality, and operational requirements into standardized, compliant LabWare LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.
Responsibilities:
Workstream Leadership & Scope Definition.
Support a dedicated workstream supporting implementation of raw material and commercial product processes within LabWare LIMS 8.
Define and manage LabWare build across.
Raw materials and commercial product master data.
Test workflows.
Laboratory equipment and interfaces.
Lab Ware LIMS Configuration:
Configure raw materials, commercial products including stability, and laboratory equipment in LabWare LIMS using standardized, compliant design patterns.
Ensure LabWare configuration aligns with:
pproved test methodologies.
Product specifications.
Sampling plans.
pply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
Requirements Traceability & Validation Support:
Translate regulatory, quality, and operational requirements into standardized LabWare LIMS designs.
Support validation activities by providing clear documentation and traceability for configured LabWare objects following Takeda internal procedures.
Instrument & System Integration:
Configure and support instrument interfaces between LabWare 8 and a variety of laboratory systems.
May develop or support parsing scripts, where required and permitted by Takeda standards and governance.
Support connectivity and data flow between LabWare and other GMP systems, such as LabX.
Operational Readiness & Execution:
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 LabWare configurations are fit for intended use and operationally sustainable.
