Renuka Bhimavarapu
Senior Labware Lims Developer Csv Engineer @Molina Healthcare
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WORK HISTORY
Senior Labware Lims Developer Csv Engineer @Molina Healthcare
Supporting regulated laboratory and quality systems by designing, configuring, and maintaining LabWare LIMS solutions. My work focuses on improving laboratory data management, ensuring compliance, and keeping systems validated and reliable.Key contributions-Designed and configured LabWare LIMS workflows supporting end-to-end sample lifecycle management, testing, review, and approval-Developed and maintained LIMS Basic scripts to implement business rules, calculations, validations, and automated controls-Configured test methods, result entry screens, templates, and reports aligned with laboratory and compliance requirements-Supported integrations between LabWare LIMS, laboratory instruments, and enterprise systems to ensure accurate and secure data exchange-Performed impact assessments and supported system upgrades, patches, and enhancements-Executed and reviewed IQ, OQ, and PQ testing to maintain the system in a validated state-Authored and maintained validation documentation including URS, FRS, risk assessments, traceability matrices, and validation summary reports-Worked closely with QA to ensure compliance with GxP, FDA 21 CFR Part 11, and ALCOA+ data integrity principles-Provided production support by troubleshooting configuration, scripting, and performance issues-Supported change control, deviations, CAPAs, audits, and regulatory inspections-Developed SOPs and provided end-user training and ongoing support.
EDUCATION
Jawaharlal Nehru Technological University Hyderabad (JNTUH)
Bachelor's degree, Doctor of Pharmacy (PharmD)
George Mason University
Master's degree, Master’s in Health Informatics
ABOUT RENUKA BHIMAVARAPU
Verification & Validation (V&V) Engineer with 6+ years of experience supporting regulated laboratory and quality systems within the life sciences and healthcare industry. Experienced in Computer System Validation (CSV), including development and execution of validation protocols, test plans, and validation documentation to ensure systems meet functional, performance, and regulatory requirements.My background is a mix of technical LIMS work and validation-focused delivery. I’ve worked extensively on LabWare LIMS configuration, workflows, sample lifecycle management, test assignments, result entry, and reporting, along with developing custom business logic using LIMS Basic scripting.I have strong experience in Computer System Validation (CSV) and have been directly involved in URS, FRS, risk assessments, IQ, OQ, PQ, traceability matrices, and validation summary reports. I’m very comfortable working in GxP-regulated environments and supporting compliance with FDA 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) requirements.I’ve supported LabWare LIMS integrations with laboratory instruments, ERP systems, and external applications, and I’ve been involved in system upgrades, patches, and enhancements from impact assessment through validation and production support.I enjoy working closely with QA, IT, automation, and lab teams to deliver practical, compliant, and user-friendly LIMS solutions. I’m known for being hands-on, detail-oriented, and dependable when it comes to documentation, troubleshooting, and user support.Currently, I’m open to new opportunities where I can contribute my LabWare LIMS, V&V and CSV expertise to regulated laboratory environments.
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