Narendra Palla

About Narendra Palla

Highly skilled and detail-oriented Validation Engineer with extensive experience in Equipment Validation, Cleaning Validation, Utilities, and facilities qualification within regulated industries. Expertise in Cleaning Validation Sampling, MACO Calculation, Protocols drafting. Proficient in developing, writing, and executing IQ, OQ, and PQ protocols, ensuring compliance with industry standards and regulatory expectations.Expert in drafting and reviewing User Requirement Specifications (URS), as well as leading Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to ensure seamless equipment integration and operational reliability. Strong understanding of Cleaning Validation programs, ensuring product safety and compliance with cGMP standards.Proficient in Change Control, Deviation Management, Corrective and Preventive Actions (CAPA), Investigations, and Root Cause Analysis (RCA) to drive continuous improvement and regulatory compliance. Adept at troubleshooting validation issues, mitigating risks, and ensuring robust process control strategies.Well-versed in global regulatory guidelines, including 21 CFR Part 11, GAMP 5, and ISO standards, with a strong focus on maintaining process integrity, product quality, and audit readiness. Passionate about optimizing validation processes and ensuring continuous compliance in fast-paced, high-tech environments.Let’s connect to collaborate on validation life-cycle management, quality systems, and regulatory compliance in the biotech, pharmaceutical industries.

Experience

1. Validation Engineer

   Regeneron

   Mar 2025 — Present · NY, US

Education

• Rajiv Gandhi University of Health Sciences

  Master of Science - MS, Pharmacy

• MGR Medical University

  Bachelors, Pharmacy