LabWare LIMS Validation Specialist - Thousand Oaks, CA ; Onsite

Position: LabWare LIMS Validation Specialist  - Thousand Oaks, CA 91320 (Onsite)
Location: Newbury Park

Title:

Lab Ware LIMS Validation Specialist

Location:

Thousand Oaks, CA 91320 (Onsite)
Duration: 9+ Months (Possible extension)

Job Summary
Lab Ware LIMS Configuration Specialist to support the Lab Ware 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 Lab Ware LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.
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Key Responsibilities
Workstream Leadership & Scope Definition
Support a dedicated workstream supporting implementation of raw material and commercial product processes within Lab Ware LIMS 8.

• Define and manage Lab Ware 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 Lab Ware LIMS using standardized, compliant design patterns.
Ensure Lab Ware configuration aligns with:

• Approved test methodologies

• Product specifications

• Sampling plans
Apply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
Requirements Traceability & Validation Support
Translate regulatory, quality, and operational requirements into standardized Lab Ware LIMS designs.
Support validation activities by providing clear documentation and traceability for configured Lab Ware objects following Takeda internal procedures.
Instrument & System Integration
Configure and support instrument interfaces between Lab Ware 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 Lab Ware 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 Lab Ware configurations are fit for intended use and operationally sustainable.
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Required Qualifications
Proven hands on experience configuring Lab Ware LIMS (Lab Ware 8 strongly preferred).
Strong experience with Labware within GMP laboratory operations, particularly:

• Raw materials testing

• Commercial product testing

• Laboratory equipment workflows
Demonstrated ability to translate regulatory and quality requirements into compliant LIMS configurations.
Experience supporting LIMS validation with full requirements traceability.
Experience integrating Lab Ware with:

• Instrument systems (e.g., Empower, LabX)
Strong cross functional communication skills in regulated environments.
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Preferred Qualifications
Experience supporting Lab Ware upgrades or major LIMS implementations.
Experience working in biopharmaceutical or pharmaceutical GMP environments.
Experience supporting inspection readiness activities related to LIMS.
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Deliverables & Success Criteria
Completed on time Lab Ware 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 Lab Ware and laboratory instruments
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Additional Notes
This role requires close collaboration with Quality, Validation, IT, and Laboratory teams.
Work must follow change control, validation, and data integrity requirements.
Onsite presence may be required based on project phase and site needs.

Benefits:
We offer a competitive compensation package that includes:

• Pay Rate: $80 - $90 per Hour
  • 
    
    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.