Biotech and Pharmaceutical, Bug Tracking/Defect Management, Change Control, Change Management, Communication Skills, Consulting, Cross-Functional, Data Quality, Documentation, GMP (Good Manufacturing Practices), Laboratory Information Management System (LIMS), Labware, Organizational Skills, Problem Solving Skills, QA Partner Testing Software, Quality Assurance, Requirements Management, Requirements Validation/Verification, Support Documentation, Test Requirements, Testing, Traceability, Validation Documentation, Validation Testing
Job Title: LabWare LIMS Implementation & Validation Support Specialist (LabWare 8)
Location: Onsite California Preferred (Open to Remote/Hybrid)
Duration: 10 Months
Start Date: ASAP
Job OverviewWe are seeking a LabWare LIMS Implementation & Validation Support Specialist to support a LabWare 8 upgrade project within a regulated GMP laboratory environment. This role will focus on validation support, documentation coordination, requirements traceability, testing activities, and deployment readiness across LIMS configuration and instrument integration workstreams.
The ideal candidate will have experience supporting LabWare LIMS implementations/upgrades, GMP validation processes, and cross-functional collaboration with Quality, Validation, IT, and laboratory teams.
Key Responsibilities- Support LabWare 8 implementation activities, including configuration and instrument integration workstreams.
- Coordinate requirements gathering, documentation, testing support, and traceability activities.
- Assist with preparation and maintenance of validation and implementation documentation.
- Partner with Quality Assurance, Validation, IT, and laboratory teams to support compliant deployment.
- Support testing cycles, defect tracking, issue resolution, and change management activities.
- Assist with deployment readiness and ensure configured workflows are sustainable in GMP laboratory environments.
- Support communication and coordination between technical and business stakeholders.
Required Qualifications- Hands-on experience supporting LabWare LIMS projects in regulated GMP environments.
- Understanding of GMP validation processes, requirements traceability, and regulated documentation practices.
- Experience supporting LIMS implementation, testing, validation, or deployment activities.
- Strong coordination and communication skills across Quality, IT, Validation, and laboratory teams.
- Ability to work independently in fast-paced implementation environments.
- Pharmaceutical or biopharmaceutical industry experience preferred.
Preferred Qualifications- Experience with LabWare 8 upgrades or large-scale LIMS implementations.
- Exposure to LIMS configuration and instrument integration activities.
- Experience supporting GMP data integrity, change controls, and validation lifecycle processes.
- Background as a LabWare Functional Consultant, LIMS Implementation Specialist, QA Systems Specialist, or Validation Coordinator.