ASHOKKUMAR G

Bangalore

Summary

Skilled Engineer with 8 years of experience in System Validation (5 years), analytical instrumentation and BMS (3 years). Expertise in installation, commissioning, calibration, and validating Testo Saveris CFR systems per FDA 21 CFR Part 11, GAMP 5, and EU Annex 11. Experienced in authoring IQ/OQ/PQ protocols, managing User Requirement Specifications (URS), and conducting Root Cause Analysis (RCA) to ensure data integrity and regulatory compliance.

Overview

years of professional experience

Work History

Solution Service Engineer

Testo India Pvt. Ltd.

01.2022 - Current

CSV Execution: Lead end-to-end validation for Testo Saveris CFR ecosystems, ensuring systems meet stringent electronic record and signature requirements.
Validation Support: Managed IQ promotion executions in QA and Production environments, performing electronic execution to ensure compliance with CSV verification standards.
Protocol Management: Author, review, and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
Risk Assessment: Drafted and executed Requirement Risk Assessments (RRA) to identify and mitigate potential system failures, enhancing system reliability.
Software Commissioning: Configure Saveris Professional software, performing database setups and critical firmware migrations for wireless/Ethernet monitoring components.
RCA & Troubleshooting: Investigate system breakdowns and data communication issues, performing deep-dive Root Cause Analysis (RCA) to ensure 99.9% system uptime.
Training: Delivered pre-execution training to client IT and Local Deployment Teams (LDT) on document creation and ValGenesis-compliant workflows, empowering teams for effective implementation.

Service Engineer

Technovalue Solutions Pvt. Ltd.

09.2020 - 11.2021

Calibration & Maintenance: Conducted preventive maintenance and calibration of high-precision analytical instruments, ensuring compliance with NABL standards.
Compliance Documentation: Compiled and organized service reports and calibration certificates to support pharmaceutical and HVAC audit processes.
Provided technical support for clients using company products and services.
Diagnosed equipment issues and performed necessary repairs efficiently.
Conducted routine maintenance to ensure optimal performance of systems.

Sales Engineer

Centum Controls Pvt. Ltd.

02.2018 - 08.2020

Analyzed requirements through site surveys to establish User Requirement Specifications (URS) for industrial automation projects.
Crafted comprehensive technical proposals and Design Specifications for process control solutions, ensuring alignment with client needs.
Collaborated with clients to understand technical requirements and provide tailored solutions.
Demonstrated product features through presentations and hands-on demonstrations.
Developed technical documentation to support product installation and usage.

Education

B.E. - Electronics & Instrumentation

Muthayammal Engineering College

Rasipuram

07-2016

Skills

Validation Standards: GAMP 5
Regulatory Compliance: 21 CFR Part 11
EU Annex 11
ISO/IEC 17025
GxP Standards
21 CFR compliance
UAT
RRA (Requirement Risk Assessment)
Quality Assurance: Data Integrity
Audit Trail Reviews
CAPA
Software commissioning
URS documentation
Design specifications
Traceability matrix

Design Specifications (DS)
Data integrity assurance
VSR
System Expertise: Testo Saveris 1
System Configuration
Software: Testo Saveris CFR
ValGenesis (Familiarity)
Adobe Acrobat (AMS Project)
MS Office
Hardware: Thermal Imagers
Instrumentation Calibration
Humidity/Temp Transmitters
PLC Interface
Professional Software Commissioning

Accomplishments

Rookie of the year (2022)

Timeline