Automation Engineer Change Management
Resume:
Sanjay Venkatesh
*************@*****.***
PROFESSIONAL SUMMARY
Automation Engineer experience in manufacturing sites in the Quality Control (QC) laboratory and facility support systems.
Provided technical knowledge and expertise to develop and execute the qualification and validation programs ensuring adherence to SOPs.
Computerized Systems Validation: Automated Systems, Control Systems, PLC, HMI, SCADA, Safety PLC, Safety Control Systems, IT Infrastructure.
Provided qualification, validation, and change management support and oversight for complex equipment and facilities projects.
SDLC (Software Development Life Cycle), V-Model, SQL Queries and Agile experience.
Performed technical review of cGMP documentation, including change controls.
Evaluated, developed, and implemented program improvements for the qualification, validation, change management, calibration, and maintenance programs for equipment, facilities, and laboratory instrumentation.
Developed and reviewed pre and post execution qualification and validation protocols (IQ, OQ, and PQ), calibration forms, and change management documents of equipment, facilities, and laboratory instrumentation.
Maintained the qualification protocols, forms, and change control files.
Skilled in providing technical oversight, establishing standard work practices, and ensuring integration with external systems in the pharmaceutical industry.
SKILLS
Software: Rockwell RS Logix 5000, FactoryTalk View, Delta V, OSI PI, ANSYS, CATIA, SolidWorks, MATLAB, Minitab, AutoCAD, SCADA, LabView Quality: DFMEA, Root Cause Analysis, DOE, FEA, Continuous Improvement, Gauge R&R. MS Office: Word, Excel, PowerPoint, Outlook, SharePoint
EDUCATION
Master of Engineering, Mechanical Engineering, Montana State University (MSU) Bozeman, MT
Bachelor of Engineering, Mechanical Engineering, Bangalore Institute of Technology (BIT) Bangalore, India
PROFESSIONAL EXPERIENCE
Cytiva, Marlborough, MA Oct 2024-Present
Sr Validation Automation Engineer
Worked in collaborating and resolving FAT defects, server and switch configuration on a PlantPAx platform
Designed and implemented cutting-edge automation solutions for bioprocessing systems, improving operational efficiency and reducing manual errors in biomanufacturing.
Utilized advanced automation platforms to monitor and control bioreactors, filtration systems, and chromatography processes, ensuring product quality and regulatory compliance.
Collaborated with cross-functional teams to design and optimize automated systems for upstream and downstream processes in biotech production.
Worked on Developing protocols for FATs for Mixers, Bioreactors, filtration skids.
Utilized advanced tools to monitor automated systems for process performance, identifying opportunities for improvement and mitigating potential process failures.
Contributed to continuous improvement initiatives by identifying and implementing cost-effective automation solutions that enhanced production throughput and minimized waste
Bei Gene, Hopewell, NJ Feb 2024 – Sep 2024
Automation Engineer
Conducted validation and testing of DCS/EMS setups to ensure they met regulatory requirements and operational needs, supporting successful audits and inspections.
Implemented and configured DeltaV or Syncade MES for pharmaceutical manufacturing facilities, enabling streamlined process management and data integration
Conducted regular maintenance, troubleshooting, and support for OSI PI systems to ensure high availability, reliability, and data integrity.
Execution of the logic of the PLC program using Studio 5000, HMI, Rockwell Automation PlantPAx, FactoryTalk View Studio, and Logix Designer Compare Tool for Allen-Bradley PLCs by following a predefined protocol.
Used Python to create simulation models for testing and validating control strategies and system performance before deployment.
Participated in cross-functional teams for continuous improvement in IO Checks and performed Risk Analysis (GAMP5 techniques) to ensure compliance with cGMP/GLP and FDA regulations.
Technical proficiency OSI PI Historian and management of the PLC from Rockwell Automation.
Led quality assurance (QA) validation activities for automation systems in pharmaceutical manufacturing, ensuring compliance with regulatory requirements and industry standards.
Developing and implementing Excel macros to automate repetitive data analysis tasks.
Managed and executed program backups to ensure data integrity and system reliability.
Conducted comprehensive IO checks and managed Water for Injection (WFI) systems to maintain operational efficiency and compliance.
Created comprehensive training materials and conducted training sessions for end-users and technical staff on OPC UA, DA, and AE technologies.
Programmed Moxa MB3170 for Cryogenic Storage Vessels and Moxa io Logik for incubators, enhancing system control and monitoring capabilities.
Provided support for EMS IO checks to ensure proper functioning and integration.
Developed and implemented SCADA and HMI system programming for efficient process control and user interface.
Strong Quality in cGMP, GDP, GAMP 5, GAMP 4 and FDA Regulatory compliance knowledge and experience.
Developed and maintained standard work practices for DeltaV configuration and testing within the pharmaceutical industry.
Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP)
Generated and managed documentation related to control system configuration, including control narratives, instrument lists, and control logic descriptions, to facilitate system understanding and troubleshooting.
Reviewed, set up, and configured ABB Variable Frequency Drives (VFDs) to optimize motor performance and energy efficiency.
Exclusively working with PLC’s and Softwares like ABB/Bailey Infi90, AB Allen-Bradley PLC5, SLC500 Series and Rockwell FT View SE, Rockwell Automation, PlantPAX, Rockwell PLC, Studio 5000,Factory Talk SE, Factory Talk Historian, Factory Talk Batch, Factory Talk alarm and events,S88, Batch, Historian, Control Logix 1756.
Conducted thorough assessments of process requirements to determine the appropriate DCS hardware and software components, enhancing system performance and reliability.
Designed and implemented Moxa ioLogik solutions for incubator control systems, ensuring precise environmental conditions for sensitive pharmaceutical products.
Created detailed Rockwell Automation (RA) Control Panel drawings for various pharmaceutical manufacturing systems, ensuring accurate representation of control components, wiring, and layout.
Generated Bill of Materials (BOM) based on control panel drawings, facilitating procurement and assembly of control panel components
GlaxoSmithKline (GSK) Pharma, Marietta, PA Feb 2023 – Jan 2024
Automation Engineer
Managed system validation for pharmaceutical automation system, ensuring GXP compliance and regulatory adherence.
Performed review and continuous improvement of automation documents, improving efficiency of laboratory applications.
Developed custom scripts and automation routines using UA Expert and OPC tools to streamline data collection, processing, and reporting.
Developed and managed recipes using S88 guidelines to ensure repeatable and reliable batch processes in manufacturing environments.
Developed and maintained SOPs for automation maintenance, resulting in operations and minimized undesirability issues and Quality functions
Conducted root cause analysis and managed corrective actions for automation issues, reducing system downtime.
Implemented automation maintenance, including device selection and integrations, leading to enhanced process automation systems.
Maintained SDLC documentation and managed automation projects, and monitored system security enhancements, enhancing data management and protecting against cyber threats.
Specializations in Allen Bradley/Rockwell Automation, Modicon / Schneider Electric, Siemens Industrial and Inductive Automation (Ignition) SCADA.
Performed and started up maintenance tasks for the Siemens PLC, FTBatch, Plant PAX, SQL Server queries, Platform, ME, and FT View SE systems.
Following Current Good Manufacturing practices (cGMP) and Good Document practices (GDP).
Reviewed and approved change control and testing document, conducting testing and reporting and investigated and resolved equipment automation issues through troubleshooting approach.
Worked with protocols for execution of SIP Probes installation, integrity test of gloves for filing lines and performed cleaning validation on SIP station.
Utilizing GAMP 5 V-Model guidelines to ensure systems are designed with quality and compliance in mind from the outset.
Authored/revised automation life cycle documents (FS, SDS, HDS etc.).
Managed automation initiatives, integrating AI/ML capabilities for predictive maintenance, optimizing equipment performance.
Conducted system audits, providing services support for laboratory applications, and programmed, configured, and maintained PLC systems, including Allen Bradley and Schneider, ensuring uninterrupted operations.
Provided programming and control services for Allen Bradley Control Logix automated systems, and Factory Talk HMI system upgrades, as well as controlling phases of medication freeze drying projects.
Proved experience specifying and programming industrial control systems, including PLCs (RS Logix 5000), HMIs, SCADAs, and motion control systems.
Applied control algorithms to optimize manufacturing processes, resulting in improved yield, reduced cycle times, and adherence to pharmaceutical quality standards.
Designed and modified Wonderware ArchestrA and plc program as per project requirements.
Worked with global and local team to connect the system to OSI-PI data historian and setup over OT network as per project requirements.
Pfizer, Kalamazoo, MI Jan 2022 – Jan 2023
Automation Engineer
Authored and executed automation verification protocols for Freeze Dryers, CIP Skids, IPEC skids and Tanks.
Participated in the development of automation system life cycle documents to meet cGMP requirements (i.e., validation, SOPs, periodic review, and PM).
Assisted in review and validation of automation documents for continuous improvement.
Developed and managed EMS (Environmental Monitoring System) IO Lists to accurately track and control critical environmental parameters such as temperature, humidity, and air quality in pharmaceutical facilities.
Carried root cause analysis, incident investigations and troubleshooting interdisciplinary issues. Related to mechanical, electrical, instrumentation, and equipment control.
Verified software functionalities such as alarm verification, I/O testing, loop checks, interlocks, tag mapping, memory mapping for process automation systems Allen Bradley PLC (RS Logix 5000) and HMI/SCADA (iFIX, FactoryTalk View). Performed engineering walkdowns on P&IDs, System and Electrical Drawings.
Implemented automation maintenance, including device selection and integrations, leading to enhanced process automation systems.
Implementing checks and validations within macros to maintain data integrity and accuracy.
Created Python-based tools for automated testing and validation of control systems.
Ensured all automation projects adhered to GAMP 5 V-Model guidelines, promoting a risk-based approach to validation and compliance.
Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP)
Maintained, troubles hooted, and supported control networks, Honeywell, and PLC controlled manufacturing equipment, and understanding the impact of actions on the equipment in manufacturing and facilities.
Developed and implemented solutions for protocol conversion between OPC standards and other industrial communication protocols to enhance interoperability.
Validating control and automation systems such as Allen Bradley PLC’s, SCADA, HMI, Building Automation Systems (BAS), FTBATCH, FT Recipe Editor, Smartsheet, Wonderware system, PlantPAx (Allen Bradley), FT VIEW ME & FT VIEW SE systems.
Proficient in designing, programming, and troubleshooting Programmable Logic Controllers (PLCs) to ensure efficient control and automation of pharmaceutical manufacturing processes on the plant floor
Involved in Software Development Life Cycle (SDLC), from requirements gathering to system deployment, ensuring automation projects met deadlines.
Performed technical review of cGMP documentation, and testing document including change controls.
Developed and validated automation systems, ensuring GXP practices were consistently followed.
Supported and troubleshooted controls network and PLC controlled manufacturing equipment while understanding impact of actions to Manufacturing and Facilities equipment.
Verified recipe parameters, batch end reporting, data historian for Freeze Dryers, Automatic Loading/Unloading System (ALUS) and Tanks on HMI/SCADA (iFIX, FactoryTalk View).
Generated and reviewed design and commissioning documents such as system requirements, engineering protocols for Rockwell RS Logix 5000 and FactoryTalk View.
Performed data integrity (DI) assessments to verify electronic records, E-signatures, audit trails, data backup/restore functionalities as per 21 CFR part11.
Identified discrepancies in software and troubleshooted PLC program.
Developed a dashboard to track potential roadblocks in commissioning activities and monitor the issues status.
Validated and verified the different alarms and PLC ladder logic for freezer dryer unit.
Amgen, Dallas, TX Oct 2018 – Dec 2021
Automation Engineer
Developed validation and testing documentation such as Validation Plan Summaries, Test Plans Summaries, URS and FRS, RTM, Qualification Protocols and scripts for Allen-Bradley, PLC, HMI and MES applications as well as documentation of testing defects
Automated the generation of technical and operational reports using Python, streamlining reporting processes and improving data accuracy.
Reviewed technical documentation including protocols & summary reports for CQV lifecycle documentation, other testing, and validation SOPs.
Ensured all automation, process control, and GMP software applications (HMI, PLC, SCADA) are validated and maintained, as well as ongoing re qualifications.
Facilitated discussion to define system criticality according to FDA regulations and performed risk assessment to create Quality Assurance Plan and Data Migration Plan.
Collaborated with Quality Assurance teams to ensure that all automation projects met GAMP 5 standards and regulatory requirements.
Designed and supported food industry process and packaging systems using primarily Rockwell PLCs with emphasis on the Logix5000 platform.
Executed validation protocols, ensuring the accuracy and reliability of automated manufacturing processes, with a focus on OPC and Ethernet communications.
Utilized OSI PI tools to perform advanced data analysis, trend analysis, and generate comprehensive reports for process optimization and decision-making.
Collaborating with Verification Engineering in executing the equipment test followed by generating reports for Non-conformances, implementing code changes and Re-testing the equipment.
Provided programming and control services for Allen Bradley Control Logix automated systems, and Factory Talk HMI system upgrades, as well as controlling phases of medication freeze drying projects.
Developed Traceability Matrix to keep track of relationship between Requirements and Test Scripts. Conducted assessments of regulated systems to assure validation procedures have been followed incompliance with company, divisional and departmental policies, and predicated rules.
Reviewed test scripts for IQ/OQ/PQ and coordinated with Honeywell to make sure the system gets qualified through complete IQ/OQ/PQ execution.
Developed UAT scripts for the system testing and performed dry run to find out the issues in system before the final UAT execution.
Managed bug tracking cycle with daily release calls with developers and various members of team to discuss and resolve defects arose during the UAT (User Acceptance Testing) execution.
Generated Bug Report showing Nature of Error in terms of Minor, Major and Critical and developed matrix report using HPQC.
Worked on QA Summary Report and Requirement Traceability Matrix (RTM).
Ensured consistent coordination and implementation of changes to GMP facilities, utilities, equipment, computerized process control and information systems, as well as controlled documents.
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