Acceptance Testing, Biology, Biotech and Pharmaceutical, Communication Skills, Configuration Management, Data Management, Documentation, Equipment Validation, GMP (Good Manufacturing Practices), Instrumentation, Laboratory, Laboratory Equipment, Laboratory Information Management System (LIMS), Laboratory Operations, Laboratory Systems, Labware, Maintain Compliance, Master Data Management (MDM), Materials Testing, Medical Equipment, Operational Support, Product Testing, Project Execution, Project Lifecycle, Quality Assurance Methodology, Regulatory Compliance, Regulatory Requirements, System Integration (SI), System Test, System Validation, Technical Leadership, Technical Writing, Testing, Time Management, Traceability
Hi,
My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
Role: LabWare 8 LIMS Configuration & Integration Specialist
Location: Thousand Oaks, CA - Hybrid
Duration: Through March 2027 (Potential Extension)
Position Overview
We are seeking an experienced LabWare 8 LIMS Configuration & Integration Specialist to support a large-scale LabWare 8 upgrade initiative within a GMP-regulated pharmaceutical laboratory environment. This role will lead critical workstreams focused on configuring raw material and commercial product testing workflows, master data management, equipment integration, and validation support.
The ideal candidate will have extensive hands-on experience with LabWare 8 configuration, laboratory system integrations, and GMP laboratory operations, with the ability to deliver compliant and scalable LIMS solutions.
Key Responsibilities
- Configure and implement LabWare 8 LIMS workflows supporting raw material and commercial product testing processes.
- Lead master data configuration and management activities to support laboratory operations.
- Design, configure, and optimize laboratory workflows while ensuring compliance with GMP and regulatory requirements.
- Support integration of LabWare 8 with laboratory instrumentation and enterprise systems.
- Collaborate with Quality, Validation, Laboratory Operations, and IT teams to ensure successful project execution.
- Translate business, quality, and regulatory requirements into compliant LIMS configurations.
- Support system validation activities, ensuring complete requirements-to-configuration-to-validation traceability.
- Troubleshoot configuration, workflow, and integration issues while driving timely resolution.
- Assist with user acceptance testing (UAT), system testing, and deployment activities.
- Support inspection readiness efforts and ensure compliance with regulatory expectations for computerized systems.
- Provide technical guidance and documentation throughout the project lifecycle.
Required Qualifications
- 8+ years of experience working with Laboratory Information Management Systems (LIMS).
- Strong hands-on experience configuring and implementing LabWare 8 LIMS.
- Proven experience supporting LabWare upgrades, implementations, or enhancement projects.
Experience configuring workflows for:
- Raw Material Testing
- Commercial Product Testing
- Laboratory Equipment and Instrument Workflows
- Demonstrated experience supporting GMP-regulated laboratory environments.
- Experience integrating LabWare with laboratory instruments and enterprise systems.
- Strong understanding of computerized system validation (CSV) principles and documentation requirements.
- Experience supporting validation deliverables with end-to-end traceability.
- Excellent communication and stakeholder management skills within regulated environments.
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Stark Pharma Solutions Inc