Title: LabWare LIMS Validation Specialist
Location: Thousand Oaks, CA 91320
Duration: 9+ Months
Hybrid, remote, onsite: Onsite
SHPGJP00010107- (Onsite role preferred. Option for Remote for the correct candidate)
Job Description:
Job Summary
- 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.
Key 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
- LabWare 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:
- 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 LabWare LIMS designs.
- Support validation activities by providing clear documentation and traceability for configured LabWare objects following Client’s 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 Client 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.
Required Qualifications
- Proven hands on experience configuring LabWare LIMS (LabWare 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 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 working in biopharmaceutical or pharmaceutical GMP environments.
- Experience supporting inspection readiness activities related to LIMS.
Deliverables & Success Criteria
- Completed on time 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
Additional Notes
- This role requires close collaboration with Client’s Quality, Validation, IT, and Laboratory teams.
- Work must follow Client’s change control, validation, and data integrity requirements.
- Onsite presence may be required based on project phase and site needs.