Dayakar P
Bowie,MD
Overview
8
8
years of professional experience
Work History
Automation Engineer
Indian Immunologicals Human Biologicals Institute
01.2021 - 08.2022
- Responsible for electronic document management systems (e.g
- Documentum, Qumas, SharePoint etc.); application development and lifecycle management
- Develop equipment operating procedures, which include start-up, shutdown, troubleshooting, calibration
- This documentation was then made available locally and via intranet system which utilized step by step instruction with the use of integrated photos, CAD layouts, and control equipment documentation
- Design and program PLCs (Allen-Bradley, Siemens, etc.) to control machinery and equipment, ensuring seamless integration with MES software
- Create and optimize Human-Machine Interfaces (HMIs) for real-time monitoring and control of manufacturing operations
- Collaborate with operations teams to troubleshoot and resolve automation-related issues, minimizing downtime and ensuring consistent production
- Reviewed computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix, to Production Statements
- Ensure continuous laboratory data integrity and identify any data integrity issues
- Assisted with the development of processes and procedures to ensure the efficient and compliant technical operations of GMP systems
- Actively participate in continuous improvement initiatives, identifying opportunities to enhance system performance and reduce costs
- Maintain documentation of system configurations, schematics, and troubleshooting procedures
Controls Automation Engineer
Indian Immunologicals Human Biologicals Institute
09.2020 - 11.2021
- Responsible for conceptualizing, validating and documenting designs, while also creating PLC systems like Siemens and Allen Bradley PLC, as well as HMI interfaces for use in industrial machinery
- Performed PLC Programming and troubleshooting Rockwell, Allen Bradley, integrating with the hardware team for supporting design layout and implementation
- Led the design and implementation of advanced control systems for critical medical device manufacturing processes, resulting in a reduction in defects and an increase in production yield
- Upgraded the HVAC system with energy-efficient components, resulting in a reduction in energy consumption
- Drafted URS, Detailed Design Specifications (DDS), Functional Specifications, GAMP5 assessments, Alarm Assessments, Risk Assessments, performed Computer System Validation (CSV) activities for Process control, SCADA, and automation systems, Delta V
- Drove projects through a change control process, ensuring completion of all activities within compliance with formal design reviews, FMECA reviews and design verifications
- Implemented data analysis techniques to monitor control system performance and identify trends, facilitating data-driven decision-making for process improvement initiatives
- Developed advanced control strategies for power plant automation, optimizing process efficiency and reducing downtime
- Assisted in programming Allen Bradley PLC operations, defining and developing test procedures and performing design verification
- Assisted in designing and troubleshooting the SCADA system, evaluating PLC and HMI software, equipment control requirements and methods
- Participated in developing and executing validation protocols for mechanical and electrical controls, automated robotic systems such as PLC and processes used in manufacturing
Computer System Validation Engineer
Caplin Point Laboratories Ltd
02.2018 - 11.2020
- Experienced CSV IT professional with oriented pharmaceutical management professional with progressive experience (Quality, Validation and Data Integrity) in facilitating corporate success through technology implementation and process improvements
- Experience in CSV, Data Integrity, Quality Operations, Data backup and restore, Quality Systems (CAPA, Quality Incidents, Change Controls), Project Management, IT Quality Risk Management & Compliance, FUSE Validation, Commissioning & Qualification, Analytical Lab Systems, Business Consulting, Resource & Cost Estimation, Team Leadership, Vendor Assessments, Internal/External Audits, Engineering & Technical services
- Working knowledge of Compliance Risk Domains GxP, 21 CFR Part 11, Annex 11, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 820, HIPAA, DQSA, Safe Harbor, Privacy (PI, SPI), PCI DSS regulations and ISPE GAMP 5, USP 1058, ICH guidelines
- Implemented GxP compliant qualified IT infrastructure program and authored IT policies and procedures that will support GMP systems
- Performed Periodic Reviews and Requalification of GMP Critical systems including Temperature Controlled Environments
- Maintain GxP computerized systems and Analytical Equipment in validated state throughout its lifecycle and manage validation documentation in collaboration with Quality Assurance team
- Expertise in development of Validation Plans (VP), Validation Protocols (Installation Qualification, Operational Qualification and Performance Qualification), Requirement Traceability Matrix (RTM) and Summary Reports (Validation and Test Summary Reports, VSR/TSR)
- Experience in developing test plans (i.e., integration, stress and UAT) schedules, test cases, scripts, execute tests, evaluate, and review test data and Requirement Traceability Matrix
- Experience with Qualification of Pharmaceutical Lab instruments such as Vi-Cell, Nova BioProfile, HPLC, Headspace Analyzer, Density Meter, Kingfisher Flex, CTUs, Axichrom Master/Columns, Downflow Booth, Spectrophotometer, SpectraMax Plate readers, Endo Toxin Analyzers, Biosafety cabinets, Autoclaves, Lyomax Freeze Dryer -Lyophilizer, Depyrogenation Oven, and Nucleocounter NC-200
- Experience in qualifying Analytical systems such as EMPOWER, CHROMELEON, Spectrum, Cary UV, Agilent Chemstation, SoftMax Pro GXP Software, EndoScan, Analyst Software, LIMS
- Performed several 21 CFR Part 11 (Data Integrity) assessments on Network based and standalone lay systems; identified gaps and suggested remediation plans
- Experience in LIMS Integration with data system, Trackwise QMS and SAP
- Good Knowledge in Corrective Action Preventive Action (CAPA) analysis of the project
Automation Validation Engineer
Shilpa Biologicals Private Limited
10.2017 - 11.2018
- Participated in developing and executing validation protocols for mechanical and electrical controls, automated robotic systems such as PLC and processes used in manufacturing
- Assessed and validated new equipment and instrumentation for its intended use, ensuring compliance with data integrity and GMP requirements
- Validating control and automation systems such as Allen Bradley PLC’s, SCADA, HMI
- Supported the team in equipment troubleshooting and program changes
- Support team in configuration and running a recipe by creating a batch in HMI and verifying the process using functional testing in the PLC code
- Perform HMI software design and programming, I/O checks, safety interlock verification, at customer site
- Involved in Change Control Documentation such as Change Request Form (CRF), Change Control Implementation Plan and Change control summary report
- Based on the investigation reports, implemented CAPA (Corrective and Preventive Action) to prevent the future deviations of the same incident
- Involved in writing Discrepancy Reports to capture discrepancy/issues/defects encountered during test execution
- Maintain documentation of system configurations, schematics, and troubleshooting procedures
- Authored and executed test documents for Verification Testing, Data integrity assessments, identified root cause, issued deviations and drafted/executed non-conformances in GMP environment for Grade C and D area and offline as needed
- Performed redline documentation for specifications, SOPs, VTs, P&IDs as needed
- Developed process for automated TFF process with Bio-burden reduction and Sterile Filtration process skids
- Developed and commissioned tanks and single use pathways for Media fill recipes/Process
- Developed IQ, OQ, and PQ of fully automated CIP skids for cleaning of Tanks and TFF skid
- Executed tests/ Analysed Scripts and migrated data in SQL environments/servers
- Supported process team and operations 24x7 with continuous Automation support for any issues and improvements during the integrated test runs, process runs (PPQs), production and CAPAs
- Performed 100’s of recipe creation and execution based of the process modification and aligned with Batch and reports specification and software(s) associated
- Performed day-to-day activities and ensured the team is with the timeline based of the schedule
Embedded Software Engineer
Industech Solutions Hyderabad India
09.2015 - 06.2017
- Project involved developing a microchip PIC 17C756 based embedded system for high power electromotor protection
- Responsibilities included developing an application with Microchip PIC 17C756 micro-controller, SPI, 12C, RS-232 ESD protected interface, and Microchip serial EEPROM for storing user specified constants
- Embedded software traced 6 analog input channels in real-time and controlled time-dependent turn off
- Firmware code was implemented in Microchip assembler
- Employed robotic arm stepper motors with an ARM based microcontroller to control nozzle movement
- Used waveform generator, analog switches, and regulators
- Designed a system to distinguish sound frequencies and remove noise using MATLAB
- Environment included MATLAB/SIMULINK, CAN bus, SPI, 12C, RS232 interfaces, MPLAB, C/C++ coding for ARM based controller
- Developed and verified software for Utilities Management System (UMS), wrote Embedded C Code for various test cases based on requirements
- Experience in developing components for embedded systems using C, C++, STL, multithreading, locking, and design patterns (singleton)
- Designed low-level device drivers (USB device drivers/video/display/touch device drivers) and media gateway (audio filtering and media transport protocols)
- Developed firmware components on Embedded Linux environment, including Kernel drivers for audio/video interfacing drivers, USB interfacing drivers, and audio backend drivers for noise cancellation
- Responsible for developing cross-platform GUI controls using C/C++ shared between Windows and embedded targets
- Derived interface design requirements, conducted design reviews, and code reviews
- Environment involved CAN, LIN protocols for BCM, C/C++ coding, Embedded LINUX, PWM, USB driver modules, MATLAB/SIMULINK, JIRA, Git, DOORS
RF Engineer
Transceiver Technologies Hyderabad India
11.2014 - 02.2015
- To perform the RF Drive Test Engineer for 2G/GPRS/3G/HSPA Services by using TEMS Investigation 10.0.5
- Taking necessary actions like giving Mechanical Tilt, Re-orientation of the Antenna as wherever required for solving the coverage problem, for minimizing the Interference in the Network
- Done the RF Drive Test in Idle mode/dedicated mode
- Performing pre-drive test and post-drive test for new BTS site
- To check the coverage of one operator radio cell and compare with other operator radio cells
- This process done in the Benchmark drive test
- Analyzing the call drop occurs, handover problems, coverage issues
- Co-channel Interference(C/I) and Adjacent channel Interference (C/A) Analysis
- Collection of all drive test log files from TEMS Investigation and generate the Export file
- Analysis of Cell Global Identity (CGI) like Location Area Code (LAC)
- Handling of new cell sites, swap sites and solving the problems like handover failure and electrical tilt or mechanical tilt
- Preparing the export files from the log files and forwarding it to the optimization engineer
- In GSM drive test mainly concentrated on the Rx level which is indicates how much signal strength MS receiving
- Second parameter is Rx Quality which indicates the quality of voice
- In GPRS mainly observable parameter is RLC throughput in uplink and downlink as well as the LLC, SNDCP throughput values RF survey and its report making
Education
Master of Science - Information Systems
Wilmington University
New Castle, DE05-2024
Skills
- Project management
- Process improvement
- Automation
- Continuous improvement
Summary
Automation specialist with strong background in systems integration, process optimization, and troubleshooting. Proven ability to drive efficiency through innovative automation solutions. Known for exceptional teamwork and adaptability in dynamic environments. Skilled in PLC programming, HMI design, and robotic systems, consistently delivering impactful results. Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Timeline
Automation Engineer
Indian Immunologicals Human Biologicals Institute
01.2021 - 08.2022
Controls Automation Engineer
Indian Immunologicals Human Biologicals Institute
09.2020 - 11.2021
Computer System Validation Engineer
Caplin Point Laboratories Ltd
02.2018 - 11.2020
Automation Validation Engineer
Shilpa Biologicals Private Limited
10.2017 - 11.2018
Embedded Software Engineer
Industech Solutions Hyderabad India
09.2015 - 06.2017
RF Engineer
Transceiver Technologies Hyderabad India
11.2014 - 02.2015
Master of Science - Information Systems
Wilmington University
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