Lakshmi V

About Lakshmi V

Experienced CQV Engineer with expertise in commissioning, qualification, and validation of utilities, facilities, and process equipment within GMP-regulated pharmaceutical and nutraceutical environments. Proficient in executing IQ/OQ protocols, developing and managing validation documentation, and ensuring compliance with FDA, cGMP, and ISO standards. Skilled in working with cleanroom systems, HVAC, compressors, vacuum systems, BMS, and clean utilities. Adept at troubleshooting technical issues, performing risk assessments, supporting CAPA investigations, and collaborating with cross-functional teams to deliver regulatory inspection-ready results for large-scale manufacturing and expansion projects.

Experience

1. Validation Engineer

   August Bioservices, LLC

   Mar 2023 — Present · TN, US

   I work on commissioning, qualification, and validation (CQV) of cleanrooms, utilities, and critical equipment to ensure they meet strict FDA, cGMP, and ISO standards before use in manufacturing. This includes systems like HVAC, BMS, compressed air, steam, and water. I create and execute validation protocols, maintain documentation in EDMS, and prepare clear, audit-ready reports.My role is hands-on—troubleshooting technical issues, running root cause analyses, and supporting CAPA investigations to resolve problems quickly. I collaborate with engineering, manufacturing, and quality teams to conduct risk assessments, close validation gaps, and continuously improve processes. Whether it’s requalifying systems, conducting field checks, or supporting inspections, my focus is on keeping operations compliant, efficient, and inspection-ready.

Education

• Fairleigh Dickinson University

  Master's degree, MS in biology sciences, biotechnology concentration

• JNTU Anantapur

  Bachelors degree in Pharm D, Pharmaceutical Sciences