Shibalik Deb
PLC/ CS Validation
Lankeswar
Summary
Analytical and detail-oriented PLC/CSV Validation Specialist with hands-on experience in validating control systems across GxP-regulated environments. Proficient in executing validation lifecycle activities, drafting test protocols (IQ/OQ/PQ), reviewing design documentation, and ensuring compliance with 21 CFR Part 11, GAMP 5, and ALCOA++ principles. Skilled in troubleshooting PLC/HMI/SCADA systems, understanding wiring diagrams, and collaborating with cross-functional teams. Seeking to contribute to high-impact validation or automation engineering roles in the life sciences or manufacturing sector.
Overview
3
3
years of professional experience
2024
2024
years of post-secondary education
4
4
Languages
Work History
PLC/CS Validation
Autocal Solutions Pvt.Ltd
06.2025 - Current
- Lead validation of control systems used in regulated pharmaceutical environments, ensuring full compliance with FDA, MHRA, and EU Annex 11 guidelines.
- Draft and execute IQ/OQ/PQ protocols for PLC/HMI/SCADA systems including Siemens, Allen-Bradley, and Schneider Electric.
- Review and verify engineering drawings, wiring diagrams, and panel layouts for compliance and accuracy.
- Coordinate with QA, Engineering, and IT departments for timely issue resolution and CAPA implementation.
- Contribute to data integrity assessments, including ER/ES evaluations and Part 11 audit trail verifications.
- Maintain and update documentation in accordance with GxP and GAMP 5 standards.
- Participate in client audits and respond to regulatory queries related to system validation and documentation.
IT Trainer
IIHT
05.2023 - 01.2024
- Designing and delivering structured training modules for SQL and Python
- Teaching SQL concepts such as database creation, query execution, joins, and data management
- Instruction Python fundamentals, including variables, data types, loops, functions, and basic scripting
- Providing Hands-on exercises to ensure practical understanding of concepts
Flutter Developer
Quironm Solutions
01.2023 - 07.2023
- Debugged existing application functionality and identified areas of improvement.
- Resolved customer issues related to software applications and developed solutions to address them
- Designed Restful APIs for mobile apps according to industry standards
Education
Bachelor of Technology - Computer Science
University Of Engineering and Management
Jaipur, RajasthanHigh School - Computer Science
Kendriya Vidyala Maligaon
Guwahati, AssamSkills
Microsoft office
Microsoft Word
WinCC
Jira
SQL(learning stage)
Siemens
Interests
Wanderlust, Hiking, Reading
Accomplishments
- Successfully validated HMI-SCADA system for a leading pharma company under tight regulatory timelines.
- Led a project to standardize IQ/OQ templates across all automation projects, improving documentation quality by 30%.
- Conducted training sessions on 21 CFR Part 11 and ALCOA+ principles for new hires.
Timeline
PLC/CS Validation
Autocal Solutions Pvt.Ltd
06.2025 - Current
IT Trainer
IIHT
05.2023 - 01.2024
Flutter Developer
Quironm Solutions
01.2023 - 07.2023
High School - Computer Science
Kendriya Vidyala Maligaon
Bachelor of Technology - Computer Science
University Of Engineering and Management
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