Yaswanth Reddy
Summary
Detail-oriented Validation Engineer with over 3 years of hands-on experience in the medical device industry, specializing in end-to-end equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Demonstrated expertise in developing, reviewing, and executing validation protocols and reports in compliance with FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP). Possesses a strong technical background in equipment troubleshooting and process optimization, minimizing downtime and improving operational efficiency. Well-versed in cleanroom operations, including adherence to contamination control procedures and environmental monitoring requirements. Recognized for effective cross-functional collaboration with Quality, Manufacturing, Engineering, and Regulatory teams to drive successful validation outcomes and continuous improvement initiatives. Additionally, skilled in training and mentoring associates on validation practices, standard operating procedures (SOPs), and compliance expectations.
Overview
3
3
years of professional experience
Work History
Validation Engineer
Cosette
NJ
01.2023 - Current
- Developed and executed Installation Qualification (IQ) protocols for manufacturing equipment and systems.
- Authored and reviewed IQ reports ensuring compliance with regulatory and internal quality standards.
- Created and executed Operational Qualification (OQ) protocols for new and existing processes.
- Generated and reviewed OQ reports with detailed analysis of test results and deviations.
- Performed equipment and process characterization studies to support validation activities.
- Supported CSV (Computer System Validation) by creating and reviewing validation reports and documentation.
- Reviewed Test Method Validation (TMV) protocols and reports to ensure accuracy and compliance.
- Provided support for APQ (Advanced Product Quality) activities, including protocol development and investigations.
- Conducted root cause analysis using tools such as Fishbone and 5 Whys for process and quality issues.
- Investigated nonconformances and owned CAPA activities through closure.
- Troubleshot equipment issues to minimize downtime and ensure continuous production.
- Participated in cleanroom operations, ensuring adherence to GMP and contamination control procedures.
- Trained new and existing associates on validation processes, SOPs, and compliance requirements.
- Collaborated with cross-functional teams including Quality, Manufacturing, and Engineering to ensure validation success.
- Ensured all validation documentation met FDA, ISO 13485, and company compliance.
- Executed Performance Qualification (PQ) protocols to confirm consistent process performance under routine manufacturing conditions.
- Performed risk assessments (e.g., FMEA) to identify critical process parameters and mitigate validation risks.
- Managed validation change controls, ensuring proper documentation, impact assessment, and regulatory compliance.
- Supported internal and external audits by providing validation documentation and addressing audit observations.
- Contributed to continuous improvement initiatives by analyzing process trends and implementing efficiency enhancements.
Education
Bachelors - undefined
Chemical Engineering
IndiaMasters - undefined
Chemical Engineering
USASkills
Equipment Validation (IQ/OQ/PQ)
Process Validation & Characterization
Computer System Validation (CSV)
Root Cause Analysis & CAPA
GMP / FDA Regulations / ISO 13485
Cleanroom Operations
Technical Documentation & Protocol Writing
Risk Management (FMEA)
Troubleshooting & Problem Solving
Personal Information
Title: Validation Engineer
Timeline
Validation Engineer
Cosette
01.2023 - Current
Bachelors - undefined
Chemical Engineering
Masters - undefined
Chemical Engineering