About

Kishore Beathu

Senior CSV Engineer & Automation Specialist

With over 16 years of experience in application development, maintenance, and Computer System Validation, I specialize in delivering critical validation services for the pharmaceutical and healthcare industries.

My journey began as an application programmer in IBM Mainframes, evolving through six years of application development for Banking, Insurance, and Manufacturing domains before transitioning to become a subject matter expert in CSV and automation engineering.

Today, I work as a Senior CSV Engineer, responsible for the qualification and validation of GxP automation systems for cutting-edge facilities including mRNA vaccine manufacturing sites.

Kishore Beathu - Senior CSV Engineer
Education

Academic Foundation

B.Tech (Hons) in Metallurgical Engineering & Material Sciences

National Institute of Technology (NIT) Jamshedpur, India

GPA: 7.08 | 2005 - 2009

A strong foundation in engineering principles and material sciences, providing the analytical mindset essential for understanding complex manufacturing processes and quality systems in pharmaceutical environments.

Expertise

Technical Skills

A comprehensive skill set developed over 16+ years of hands-on experience in validation and automation engineering.

Computer System Validation (CSV)
GAMP5 Methodology
21 CFR Part 11 Compliance
Annex 11 Requirements
ALCOA+ Data Integrity
Manufacturing Execution Systems (MES)
SCADA Systems (PCS7)
PLC/HMI Qualification
KNEAT Validation Tool
HP Application Lifecycle Management
Risk-Based Validation
GxP Practices
Tools & Platforms

Validation Tools

Proficient in industry-leading paperless validation and quality management platforms.

KNEAT

Paperless Validation

HP ALM

Test Management

Documentum

Document Management

Trackwise

Quality Management

Unifier

Project Controls

PIMS

Process Information

Let's work together

Looking for an experienced CSV engineer to support your validation projects? I'd love to discuss how I can help.