LIMS Validation Specialist Job Newbury Park California USA,Quality Assurance

Location: Newbury Park

Job Title:
Lab Ware LIMS Validation Specialist
Job : 26-02667
Location Newbury Park (Thousand Oaks), CA (Onsite)
Duration: 9 Months

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.

Key Responsibilities
Workstream Leadership & Scope Definition
Support a dedicated workstream supporting the 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.

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.

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.

The hourly rate for this position is between $90.00 -$100.00 per hour.

Compensation:
Factors that may affect starting pay within this range include [geography/market, skills, education, experience, and other qualifications of the successful candidate].

Benefits:
Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.

Contact:
Sunny Rajput | | URL: