MES Systems Analyst

Gopi Krishna

An experienced, detail-oriented MES & SCM Consultant with strong problem solving & project management skills

Summary :

• An Instrumentation Engineer with Masters in Manufacturing Management.

• Over 14 years of experience in process automation, quality control systems, applications design, configuration, development and testing

• Extensive experience in Requirement gathering, Implementation, Validation and Support manufacturing applications Regulus DCA (DMI Compliance Suite), APRISO Flexnet in Pharmaceuticals & Diesel engine manufacturing industry.

• Consulting: Functional expertise in complete life cycle implementation of Manufacturing Execution Systems (MES) and Supply Chain Management (SCM).

• Strong understanding of Oracle SCM modules (Inventory, BOM, WIP, Purchasing) and Laboratory Information Management Systems(LIMS)

• Project management: Gather project requirements, phase deliverables and project targets in direct liaison with client manager. Monitor progress and track issues

• Worked in USFDA, MHRA, MCC international regulations approved plants/facilities. .

• More than 10 years experience in cGMP work environments, good understanding of computer systems validation and 21CFR part11 guidelines.

• System design: Knowledge of Client/Server Architecture, Process control systems, Laboratory Data Acquisition and Analysis Systems.

• Systems implementation experience in Paper, Pharmaceutical and Automotive Industries.

• Support: Analyze, prioritize, resolve issues and coordinate with offshore support team for major changes.

• Hands on experience in Instrumentation and control systems

• Good communication skills, highly adaptable, fast learner, committed and driven to set and achieve team goals.

Work Experience

Cummins Inc.,

Columbus, Indiana.

Jan-2008 till date

As MES Consultant design and develop common MES solution for Cummins Inc. using APRISO FLEXNET (COTS) product.

• Setting up gap analysis process for Change Control Board (CCB) and evaluate all identified gaps through developed process and group them as releases.

• Document functional requirement specifications and prepare use case documents for functionalities in each release.

• Create High Level Design (HLD) document corresponding to functional requirements defined in the use cases.

• Coordinating with development team for Low Level Design (LLD) and development activities.

• Preparing test cases with functional test scenarios/steps to cover requirements defined in the use case documents.

• Setting up environments for development, packaging, simulation, training, load testing and maintaining them with latest release.

• Defining release process, preparing package and deployment using Flexnet Global Process Manger (GPM) module.

• Modeling and optimization of functionalities like repair station, quality alert, audit, order board, engine conversion, item assembly configuration.

• Constant review of standard operations (application functionalities) code for optimizing execution time.

• Involved in the development functionality of the application like Kitting Deviation, Hand Held Kitting, Failsafe, Order Board, Criteria Builder using VB.Net, ASP.Net, SQL Server2005 database, XML (interfaces Business systems with XSLT, LTM, MFD, XSD Schema)

• Design and implementation of Flexnet Archiving/Purging module to archive records from operational data base.

• Involved in setting up interface with Oracle11i ERP system through MQ Series.

• Involved in functional setups of Oracle ERP (11i) manufacturing modules (Inventory, BOM, WIP, and Purchasing).

• Supporting sites during deployment and log application issue to vendor, tracking and obtain resolutions.

Eli-Lilly and Company,

Indianapolis , Indiana

Feb-2005 to Dec-2007

As MES system analyst developed, supported and maintained EMPOWER (Waters), REGULUS DCA (DMI Compliance Suite) and LAMS (Life Cycle Asset Management System) applications.

• Involved in the preparation of customer requirements for the system and compiling them in to Functional Requirements specifications (FRS) System Requirement Specifications (SRS), Security requirements, Electronic records and Electronic signatures Requirements.

• AS – IS Study, To-Be Process design, mapping in the application by preparing traceability matrix along with test cases.

• Involved in product evaluation with respect to requirement specifications, identifying the list of configurations which need to be standardized to prevent customization

• Involved in application network architecture design and Functionality developed in VB.Net, SQL Server, and Crystal Reports.

• Carried out installations in various environments like development, test and production and prepared IQOQ protocols as part of validation.

• Responsible for conducting pilot sessions with various business areas with in the organization and get the requirements, analysis and finalize the configuration parameters.

• Developed enhancement for the application for new functionalities by coordinate with client and offshore technical development team for change management.

• Prioritize, analyze and resolve technical issues during system implementation and release development.

• Setting up test environment for each business area and demonstrate traceability to requirements.

• Escalating functional problem areas of the application with vendor for enhancements/improvements and implementation of releases.

• Managing, coordinating, planning and executing change request management from functional perspective

• Participating in strategy meeting and periodical business meeting with client

• Establishing & monitoring the processes for Issue Management, Change Management and Quality Management

Dr.Reddy’s Laboratories Ltd.,

Hyderabad, India.

June1998 to November 2004

Pharmaceutical company manufacturing finished solid dosages for USFDA ,MHRA, MCC etc regulated markets.

As Senior Executive-Instrumentation in Engineering and projects department, was responsible for procurement, installation, validation and maintenance of manufacturing, analytical systems.

• Preparation and execution of validation IQ, OQ and PV protocols for various analytical instruments, production equipments and computer based systems.

• Maintenance of analytical lab Instruments like HPLC’s, GC’s, Dissolution test Apparatus, Photometers etc. of Agilent technologies, Waters, Shimadzu, Vankel, Cary make and their spares management.

• Preparing and implementing Standard Operating Procedures (SOP), Preventive Maintenance Procedures as per cGMP, GLP guidelines.

• Configuration, Maintenance of Variable Frequency Drives of Hitachi, LG, ABB Siemens and Mitsubishi as required machine operation.

• Developed programs in C, C++ for various PLC systems.

• Preparation of user requirement specifications, evaluation of vendors, procurement, validation and maintenance.

• Involved in installation and commissioning of Honeywell HC900 Data Acquisition System for facilities environment conditions monitoring and maintaining data from integrated PLC network.

• Solution conception & involved in CRP setups of ELAN’s MES XFP, HONEYWELL’s POMS and ROCKWELL’s Propack for pilot functionalities evaluation.

• Coordinating and handling correspondence with vendors regarding maintenance of imported production, packing systems, analytical instruments and their spares management

J.K.Paper Mills Limited

January, 1997 to June, 1998

As Assistant Engineer-Instrumentation involved in installation commissioning of Fisher Rosemount PROVAX Distributed Control System(DCS) for RDH Digesters and Fiber line plants

• Configuration of application software and logic for process requirements on DCS and GE Fanuc PLC systems.

• Handled various programmable process equipments and testing field Instruments.

M/s. Sanghi Textiles Limited

May, 1995 to December, 1996

As Assistant Engineer-Instrumentation involved in specifications preparation, procurement of Fisher Rosemount RS-3 DCS and field instruments of Boiler, Turbine and Chemical boiler plants .

• Involved in erection, commissioning and maintenance of DCS system and field instruments.

• Configured system software as required for the day to day process operations on RS-3 DCS system.

• Programmed various single and multiple loop PID controllers for process applications

Computer Skills

• Operating Systems: Windows & NT

• Programming Languages: C, C++, PL/SQL, .NET, LM-90, Medoc, SLC-500

• Databases: MS-SQL Server, MS Access, Oracle10g

• Software applications : APRISO Flexnet, Regulus, Data sweep, Propack, POMS, XFP(Elan), Empower(Waters), SPF&SPI (Intergraph), Eladin(Nautilus), RS-3 & Provax(Emerson), MAXIMO, Trackwise, Calibration Manager, Ellips Windows(SCADA), Oracle 11i EBS

• Tools : Remedy, Test Director(Mercury), Documentum, Visio, Clear case.

Education

• Bachelor of Engineering in Instrumentation Technology

• MS (Manufacturing Management)

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