LabWare LIMS v7 Developer | Pharma / Biotech | GxP Environment
Help modernize laboratory systems in a regulated life sciences environment.
Industry: Biopharma
Contract: 6-12 Months to Hire.
Contract Type: W2 (paid weekly; health and 401k benefits)
Remote: Anywhere in USA. Should be able to support EST business hours
Travel: 10%-15% domestically
We are seeking an experienced
LabWare LIMS v7 Developer
to support and enhance laboratory systems in a regulated Pharma/Biotech environment. This role combines hands-on LIMS development and configuration with L2/L3 production support, system integrations, and Computer System Validation (CSV).
Location:
Thousand Oaks, CA, with support for Irvine, CA, and Madison, WI, as needed
Experience:
5–10 years
Environment:
GxP-regulated Pharma, Biotech, or Cell Therapy
Key Responsibilities
Develop, configure, and enhance LabWare LIMS v7 workflows for Sample Management, Batch-to-CoA, Environmental Monitoring, Raw Materials, Stability, and Inventory.
Develop LIMS Basic/LSL scripts, calculations, templates, custom reports, BarTender labels, and instrument interfaces.
Support LIMS integrations with ERP, MES, CMMS, and SDMS systems.
Provide L2/L3 support, troubleshooting, root-cause analysis, performance tuning, and system upgrade support.
Prepare and execute CSV documentation, including specifications, IQ/OQ, test scripts, impact assessments, and traceability matrices.
Lead change controls and deviation investigations, including root-cause analysis and CAPA.
Maintain GxP compliance, data integrity, security, and audit trails while collaborating with QC, QA, Validation, and IT.
Required Qualifications
5–10 years of hands-on LabWare LIMS v7 development in a GxP-regulated environment.
Strong experience with LIMS configuration, LIMS Basic/LSL, laboratory workflows, and system integrations.
Practical CSV experience and knowledge of 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
Experience with L2/L3 support, change control, deviation/CAPA processes, and validated system documentation.
Familiarity with ServiceNow and Veeva DMS/QMS.
Preferred:
LabWare certifications, Git/compliant DevOps practices, and ITIL or IT Service Management experience.
Interested in contributing your LabWare expertise to critical laboratory and quality systems? Please reach out to discuss the opportunity.