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    Professional Summary

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    Vijay LS Solutions
    This document provides a summary of Deepak Sai Krishna Jayanthi's professional experience and qualifications. He has over 7 years of experience in validation engineering, computer system validation, and ensuring compliance with FDA and cGMP guidelines. His experience includes developing validation protocols, executing qualification protocols, and authoring standard operating procedures. He is currently a Senior Validation Engineer at Abbott where he leads validation projects and ensures qualification documentation meets regulatory requirements.

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    Professional Summary

    Uploaded by

    Vijay LS Solutions
    60 views3 pages
    This document provides a summary of Deepak Sai Krishna Jayanthi's professional experience and qualifications. He has over 7 years of experience in validation engineering, computer system validation, and ensuring compliance with FDA and cGMP guidelines. His experience includes developing validation protocols, executing qualification protocols, and authoring standard operating procedures. He is currently a Senior Validation Engineer at Abbott where he leads validation projects and ensures qualification documentation meets regulatory requirements.

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    CQV (2)

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    This document provides a summary of Deepak Sai Krishna Jayanthi's professional experience and qualifications. He has over 7 years of experience in validation engineering, computer system validation, and ensuring compliance with FDA and cGMP guidelines. His experience includes developing validation protocols, executing qualification protocols, and authoring standard operating procedures. He is currently a Senior Validation Engineer at Abbott where he leads validation projects and ensures qualification documentation meets regulatory requirements.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    60 views3 pages

    Professional Summary

    Uploaded by

    Vijay LS Solutions
    This document provides a summary of Deepak Sai Krishna Jayanthi's professional experience and qualifications. He has over 7 years of experience in validation engineering, computer system validation, and ensuring compliance with FDA and cGMP guidelines. His experience includes developing validation protocols, executing qualification protocols, and authoring standard operating procedures. He is currently a Senior Validation Engineer at Abbott where he leads validation projects and ensures qualification documentation meets regulatory requirements.

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    of 3

    Deepak Sai Krishna Jayanthi

    949-339-7634
    [email protected]

    PROFESSIONAL SUMMARY:
     Over 7 years of experience as a Validation Engineer working on Commissioning and Qualification of manufacturing
    equipment, automated systems, validation of process and computer systems and equipment software.
     Excellent experience in computer system validation and FDA guidelines
     Excellent experience in authoring SOPs and WIs
     Familiar with 21 CFR Part 11, 820 and ISO 13485
     Developed and executed validation protocols and SOP's for Qualification (IQ, OQ, PQ) for equipment HMI and PLC
    systems, automated process equipment and packaging vision systems.
     Authored and executed FAT, SAT, Installation, and operational qualification (IOQ) and performance qualification
    (PQ) for automated equipment, systems, and Cold rooms.
     Experienced in preparing documents such as validation protocols that includes Installation Qualification (IQ),
    Operational Qualification (OQ), Performance Qualification (PQ) and Validation Summary Reports (VSR) of Controlled
    temperature units like ovens, incubators, freezers, and refrigerators.
     Authored and executed Commissioning Test Plan (CTP), Installation/ Operational Qualification (IOQ), Performance
    Qualification (PQ) for the Sterilization Systems
     Experience in Validation of HVAC Systems, RODI water systems, Utilities, and clean rooms
     Very good understanding of P&ID diagrams
     Managed all aspects of design, executed Validation Protocols such as Validation Plans (VP), Commissioning
    Protocols, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Turn Over Packages (TOP)
     Created and executed qualification protocols and accurately recorded, compiled, and summarized results using good
    documentation practices.
     Updated requirement traceability matrices for Freezers, Autoclave, and incubators
     Strong knowledge and working experience with cGxP (GMP, GDP, GLP, and GAMP) standards
     Participated and coordinated efforts to resolve investigations and CAPA.
     Knowledge on enterprise quality management software - Track Wise, enterprise document management system
     Responsible for LIMS database, training, maintenance, routine data archrivals, backups, and retrievals
     Demonstrated critical thinking skills and ability to independently develop methods and specification.
     Enthusiastic, self-motivated, highly organized team player with leadership skills and possess excellent
    communication skills.

    PROFESSIONAL EXPERIENCE:

    Abbott, IL Dec 2019 – Present


    Sr Validation Engineer
     Responsible for the creation of qualification and validation programs (Equipment, automated systems, and
    Computer Systems) for the manufacturing site, the Quality Control (QC) laboratory, and facility support systems.
     Developed critical validation lifecycle documentation to support the qualification/ validation of equipment,
    software, and facilities (IQ, OQ and PQ protocols, Operational SOPs, PM SOPs, Change Controls,
    User/Functional/Design Specifications)
     Responsible for validation and implementation of PLC, HMI and SCADA software for control systems and equipment
     Responsible for validation projects as well as provide support to manufacturing activities with process control and
    process monitoring equipment software (PLC's and HMI's) design, commissioning, and testing to meet end user
    requirements.
     Developed validation and testing documentation such as Validation Plan Summaries, Test Plans Summaries, URS and
    FRS, RTM, Qualification Protocols and scripts for PLC, HMI and MES applications as well as documentation of testing
    defects.  
     Qualified HVAC systems and performed Bioburden and Pyrogen testing for clean rooms.
     Support validation life cycle activities by commissioning, continuous process monitoring, change controls, SOP
    generation, and revalidation activities.
    Deepak Sai Krishna Jayanthi
    949-339-7634
    [email protected]

     Responsible for the preparation/ execution IQ/OQ/PQ protocols for equipment, facility, and utilities as well as
    related software. Generated qualification report and summarized the results for management review.
     Performed re-qualification of equipment, facility and utilities as required.
     Identified deviations encountered during IQ/OQ/PQ execution and worked with engineering to implement
    mitigations.
     Executed equipment qualification protocols and accurately documented results of the defined testing; then
    comparing and reporting those results to predefined/approved acceptance criteria.  
     Supported the change control process by reviewing proposed changes, performing risk assessments, and assessing
    the adequacy of verifications and validations.
     Support the NC and CAPA processes by performing investigations and root cause analysis, determining action plans,
    and driving the actions to closure. 
     Drafted SOPs for new operational equipment.
     Supported process validation and cleaning validation by providing product contact surface area, equipment
    qualification parameter ranges and challenge tests criteria to technical service.
     Worked with equipment vendors to collect equipment manual and other required documents.
     Closely worked with the maintenance & facility teams to complete new equipment installation as per project
    requirement.
     Experienced in drafting Deviation Reports when the test results failed to meet the acceptance criteria.  
     Performed Root Cause analysis for all the deviations and generated Corrective and Preventive Action plan  

    J&J, NJ Sep 2015 – Dec 2018


    Validation Engineer
     Developed and executed IQ/OQ/PQ protocols and completed reports for equipment, process utility, test, and
    software validations and revalidations.
     Developed Standard Operating Procedures, protocols, incidents, and final reports for new processes and equipment,
    in conjunction with the system owners.
     Supported department projects by assisting senior engineers on ongoing projects.
     Performed Preventive Maintenance and Calibration tasks as required following existing procedures.
     Prepared protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations,
    engineering, process, packaging, and cleaning validations.
     Responsible for Preparation and review of associated procedures, change controls, standard operating procedures,
    validation master plans.
     Executed protocol and related activities associated with validating equipment/ systems/ utilities/ processes,
    transferring new products/ processes from R&D to manufacturing, and executing process/documentation
    improvements. Performed statistical analysis for process monitoring.
     Preparation, execution, and review of laboratory equipment validations and analytical data
     Supported internal and external audits by providing data appropriate to the investigation as required.
     Developed and executed Equipment Qualification plans and protocols for manufacturing and packaging equipment.
     Generate FMEA documents, validation test protocols, validation reports, other required documents, and perform
    statistical analysis to support validation activities.
     Supported the investigation of deviations, troubleshoot problems, and determines solutions.
     Created and executed commissioning, qualification protocols, and validation protocols (CP/IQ/OQ/PQ/PPQ),
    including identification and resolution of exceptional conditions.
     Provided equipment, system and facility commissioning and qualification guidance and strategy execution during
    project planning and development phases.
     Oversaw and managed validation instrument inventory including calibrations and/or certifications.
     Reviewed technical documentation including protocols & summary reports for CQV lifecycle documentation, other
    testing, and validation SOPs.
     Performed temperature mapping and other miscellaneous validation activities.
     Managed contractors performing equipment and system commissioning, qualifications, and validation.
    Deepak Sai Krishna Jayanthi
    949-339-7634
    [email protected]

     Supported process and method transfer validation activities, as necessary by manufacturing and Quality Control
    labs.
     Reported status and progress of qualification activities or projects to the Leadership team.
     Performed investigations and implement corrective actions related to CAPAs and deviations.
     Developed technical specifications documents necessary for generation and/or execution of CQV lifecycle
    documentation.

    Amneal Pharmaceuticals, NJ May 2013 – Sep 2015


    Validation Engineer
     Responsible for validation of Process, Computer System Validation, Equipment and Instrumentation Qualification,
    Test Method Validation, and Facility and Utility Qualification
     Planned and performed validation activities, including Installation Qualification/Operations
    Qualification/Performance Qualification (IQ/OQ/PQ)
     Performed re-qualification of equipment, facility, and utilities.
     Identified deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation
    solution.
     Drafted Standard Operating Procedure (SOP) for new operational equipment.
     Compiled and analyzed validation data, wrote protocols, reports, and made recommendations for changes and
    improvements.
     Facilitated and supported validation training, change management, and periodic review of validated systems.
     Collaboratively conducted Risk Assessments and Impact assessments, and established system boundaries.
     Generation, Review and editing of Standard Operating Procedures. Review and verification of ETOP’s.
     Generation and execution of protocols for DQ, FAT, SAT, IV OV, IQ, OQ, and PQ
     Supported equipment troubleshooting and close out of discrepancies and deviations.
     Responsible for the site requalification plan execution and implementation. Streamlined testing requirements while
    maintaining regulatory and corporate compliance.
     Responsible for the preparation of site validation documentation such as qualification protocols, validation master
    plans, risk assessments and periodic reviews.

    EDUCATION:
     Master’s in Applied Computer science, Northwest Missouri State University, USA

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