Shravan Kumar Cholleti

About Shravan Kumar Cholleti

Accomplished Validation and Quality Compliance Specialist with over 6 years of progressive experience in Cleaning Validation lifecycle management, Quality systems, and cGMP manufacturing within the Pharmaceutical and Biotech industries. Demonstrated expertise in leading and executing cleaning validation strategies across manufacturing equipment, controlled cleanroom environments, and production processes to ensure compliance with regulatory and corporate standards. Involved in reviewing and optimizing verification and validation protocols to proactively identify risks, address issues, and drive continuous quality improvement. Strong background in Cleanability and Visible Limit Studies, ensuring scientifically justified and regulatory-compliant cleaning limits for high-potency and standard manufacturing areas. Led preparation and review of cleaning records and documentation for manufacturing and potent rooms, ensuring data integrity and alignment with GMP requirements. Familiar with solid oral dosage manufacturing, with a strong understanding of process flow, equipment cleaning strategies, and quality system integration. Actively drives deviation investigations, root cause analysis, and CAPA implementation related to swab failures and cleaning non-conformances. Proficient in executing dirty and clean equipment hold time studies and supporting cleaning validation activities during product transfers, capacity expansion, and process change projects. Strong knowledge in CIP/COP systems, parts washers, and glassware cleaning operations, including cycle development, optimization, and regulatory compliance. In-depth knowledge of GxP regulations (including 21 CFR Part 11), cleanroom classifications, gowning techniques, and global regulatory expectations. Skilled in cross-functional collaboration, providing clear guidance and training to manufacturing teams on validation protocols, SOPs, and best practices. Actively participates in change control boards, validation strategy discussions, and continuous improvement initiatives related to cleaning processes. Ensures robust GMP documentation control, including review, approval, and archival, maintaining high standards of data accuracy, traceability, and regulatory readiness.

Experience

1. Cleaning Validation Engineer

   Regeneron

   Sep 2024 — Present · Albany, NY, US

Education

• Wilmington University

  Master's degree, Information assurnce

• Wilmington University

  Computer and Information Systems Security/Information Assurance

• Shadan Inst. of Medical Sciences College of Nursing, Hyderabad

  Nursing

• Shadan Inst. of Medical Sciences College of Nursing, Hyderabad

  Bachelor's degree, Nursing