DOC-20240815-WA0102. (1)

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SHIVAM GOUR

Pratap Nagar, Naramadapuram MP IN


7898525811 | Shivamsairam.gour37@gmail.com

Objective

Motivated Validation Engineer with a career spent providing accurate reporting of test results. A diligent employee
tasked with validation documenting and extensive record keeping. Ready for a new validation role in the
pharmaceutical industry.

Experience

Kevin Technologies Pvt Ltd Indore 04/2024 - Current


Senior Validation Engineer
Provided technical support in the development of test plans, protocols, reports, SOPs.
Performed risk assessments on new processes and equipment.
Monitored compliance with established standards and procedures related to validation activities.
Analyzed data to ensure compliance with FDA regulations.
Maintained accurate records of all tests performed throughout the entire life cycle of a product or system.
Verint Engineer Pvt. Ltd. Bhopal 12/2012 - 04/2024
Validation Engineer
Negotiating, Project handling, efficient Teamwork planning, Documentation of entire validation process as per
SOP
Preparation and Execution of validation documents such as: URS, GAP Assessment Documents (Protocol,
Assessment reports, Remediation Protocol, QRM, Retrospective Validation VP, Retrospective VR), VPP, FRS, FRA,
DCS, CVC, VP, IQ, OQ, PQ, ATR, TM, SRC VSR and PRR, EDC OQ execution, Incident & Deviation handling
Coordination with automation engineer for proper application of 21 CFR to the system, clear understanding of
URS for logic preparation
Team management, Billing process handling, Panel wiring, installation and commissioning of PLC panel in case
of urgent requirement at site.
Medhaj Techno Concept Pvt. Ltd On-Site 09/2019 - 09/2022
Graduate Trainee Electrical Engineer
Maintained good professional relationships with suppliers and contractors.
Tested all products for correct installation and operation.
In Design & engineering of power supply/distribution system (HV / LV), power system protection, illumination
system, earthing system, etc.
Procurement of electrical equipment.
Shivgreen Solar System Pvt. Ltd. 11/2018 - 05/2019
Internship
Assisting in the design and development of solar panel systems and projects
Conducting site visits to assess the feasibility of solar panel installations
Collaborating with the engineering team to troubleshoot and resolve technical issues
Participating in the preparation of technical reports and documentation related to solar panel systems
ICAR-Central Institute of Agriculture Engineering Bhopal 04/2017 - 04/20218
Electrical and Electronics Apprenticeship
Assisting in the installation, maintenance, and repair of electrical systems, including wiring, circuits, and
electrical panels
Conducting routine checks and tests on electrical equipment to ensure safe and efficient operation
Collaborating with the maintenance team to troubleshoot and resolve electrical issues in a timely and efficient
manner

Projects Handle

API
CSV of Purified Water System, Centrifuge Operation, Fluid Bed Dryer, Rotocone Vacuum Dryer,
Solvent Recovery Plant SCADA, Environment Monitoring PLC based DAS systems, Door access
system, CDAS, Building Management System.
Formulation
CSV of Blister Packing and Inspection Machine, Tablet coating Machine, WnD Solution,
Jacketed Manufacturing Vessel, Pharmaceutical Mill(Delta Vita), Nano Mill
IT
User management application (GxP Digitize), SAP, SABA, Caliber E-Log, GAP Assessment and
remediation, Network Qualification.
QC Lab
Capping Machine, Filling & Sealing Isolater, Filtration isolater, OSMOmeter, Viscometer, UV
Probe, Sticker Labelling Machine.
Education

Bansal College Of Engineering Bhopal 05-2016


Bachelor of Engineering-Electrical and Electronics
8.25
St Paul EM School Naramadapuram 04-2012
Higher Secondary
84.00
St. Charles Hr Sec. School Naramadapuram 04-2010
Senior Secondary
80.00

Skills

Strong understanding of SDLC


21'CFR part 11
GAMP 5 guidelines, ICH Q7, US FDA guidelines, ISO9001.
Functional Testing, Software Testing, Manual Testing
Expertise in GAP Assessment Protocols
Incident and Deviation handling & audit trail review
IPC/SCADA, HMI, PLC, CDAS, EDLMS, BMS, Network system verification
Frequent used softwares: Vijeo citect, Factory talkview, Proficy iFix 5.8, Elipse E3, Zenon runtime, Chromeleon,
LIMS, Labware, Rudolph PC
QC Lab software: Tiamo, Omnic Spectra, DeltaPro, Mastersizer3000, Trios
Microsoft Office

Languages

English
Hindi

Disclaimer

I Shivam Gour, hereby declare that this resume is completely prepared by me and the information contained
herein is true and correct to the best of my knowledge and belief.

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