Lalit V.

MES architect

Working as Consultant with Rockwell. Serving multiple Pharma/Med Devices customers with implementation and expansion of MES footprint Designing the overall architecture of the MES system, considering manufacturing processes, data flow, and integration with other systems. Creating a scalable and flexible architecture to accommodate current and future business needs. Requirements Gathering and Analysis: Collaborating with stakeholders to understand business requirements related to manufacturing operations. Analyzing and documenting functional and technical requirements to guide system development. Technology Selection: Selecting appropriate technologies, platforms, and tools for building the MES solution. Evaluating and choosing software, hardware, and communication protocols that align with organizational goals. Integration Management: Ensuring seamless integration between the MES system and other enterprise systems (e.g., ERP, SCADA). Defining data exchange protocols and APIs for effective communication. Customization and Configuration: Customizing or configuring MES solutions to meet the specific needs of the organization. Defining workflows, user interfaces, and data models based on manufacturing requirements. Security Implementation: Implementing robust security measures to protect manufacturing data. Establishing access controls, authentication mechanisms, and encryption to ensure data integrity and confidentiality. Testing and Validation: Overseeing testing processes to ensure the MES system meets quality and performance standards. Participating in validation activities to comply with industry regulations and quality standards, Training and Support.

• Manufacturing Execution System delivery manager : design and implementation of end-to-end MES solutions, with a focus on leveraging advanced technology to improve efficiency, reduce costs, and optimize manufacturing processes. o MES Strategy Development and Execution o Cross-functional Team Leadership o Vendor Selection and Project Management o Business Process Optimization o Data Analytics and Performance Metrics o Compliance and Quality Management o Change Management and Training • Lead integration with DCS, PCS, IoT, Equipment, FTBatch, SAP,LIMS, Label Management • Lead OT initiatives on MES , Label Management and machine integration • Rockwell FTPS and Siemens Opcenter Execution Medical Device and Diagnostics (Camstar) to build operational technology (OT) for medical devices; • Develop and collaborate MES Roadmap including but not limited to lifecycle upgrades, deployment of new OT and IT standards, business standards, cutover plan and provide technology guidance to sites; • Perform creation and maintenance of MES configuration and Master Data to ensure the integrity of the data and guarantee GMP (Good Manufacturing Practice) compliance; • Provide business systems analysis support to internal customers and external trading partners for MES implementation and new functionalities within MES to improve business processes; • Coordinate project and product lifecycle (planning, scope definition, design, execution and delivery) discussions and plan product roadmap for the sites including 3-5-7 year • lifecycle, multi-year deployment strategy; • Educate, sensitize, and manage the expectations of customers to OT realities, challenges, and fundamentals; • Manage technology and integration vendors to ensure projects meet specifications, and are delivered on time; • Track progress against milestones, budgetary guidelines or other performance indicators, and prepare reports to senior management;

MES Strategy Development and Execution Cross-functional Team Leadership Vendor Selection and Project Management Business Process Optimization Data Analytics and Performance Metrics Compliance and Quality Management Change Management and Training

AMPS Program at Pfizer and support Rockwell Automation’s MES software - Factory Talk Pharma Suite (FTPS) – across the globe for one of the top leading company Pharmaceutical Implementation and Deployment of MES at Kalamazoo MI, Pear Rive NY and global building block delivery for 25 sites across globe. Responsibilities: Expertise in working and collaborating with teams across the globe following onsite-offshore model, lead 20 member team located globally. Replacing legacy systems / paper batch records with FTPS software. Interface with SAP, DCS, PCS, DeltaV with MES Process Automation standardization Collaborate with different teams from Manufacturing, SAP & Supply Chain, Product Engineering, Quality Assurance and Training to delivery robust MES implementation strategy Implemented MES in multiple pharmaceutical manufacturing plants in North America. Change management & training effort for MES implementation in one of the manufacturing plants. Designed and authored multiple pharmaceutical recipes following S88 industry standard and ensuring adherence to 21 CFR PART 11. Leading and providing subject matter expertise on manufacturing process standardization (standardized “building block" library) Designed and developed training collateral's for Manufacturing Execution (FTPS) Shop floor and on call production support Environment: Rockwell FTPS, TrackWise, HP Quality Center, Oracle, SAP, JAVA, MS-Office, PCS, DCS, DeltaV

Design, implement and support CAMSTAR MES and other manufacturing applications at multiple sites. Responsibilities: • Involved in design, test and implementation of MES application • Reverse Engineered the code to write design documents for different modules. • Analyzed business requirements, business process and system architecture/design. • Assisted in establishing and managing a common SDLC process for all regulated system development/procurement • Review regulated documents (SOPs, Policies and Procedures) • Test Planning, Review, Execution, Traceability and reporting. • Mitigate the risks to system quality and obtain stakeholder support for this plan. • Ensure the timely delivery of different testing milestones. • Prepares / updates the metrics dashboard at the end of a phase or at the completion of project. • Ensure content and structure of all Testing documents / artifacts is documented and maintained. • Document, implement, monitor, and enforce all processes for testing as per standards defined by the organization. • Keep track of the new requirements / change in requirements of the Project. • Training and responsible for UAT phase. • User Support – on call and shop floor Environment: CAMSTAR MES, Framework 3.5, SAP XI- Business Objects, VB.Net, XML, Oracle 10g, Clear TOAD, Quest, Req Pro, PDM, REMEDY.

mShare MES

Software Testing .Net3.0, SQLServer 2005 Share Point, VSTF, Product Studio

Software testing Quality Assurance Agile

BAMS a project .net SQL Test engineer, was resposible for all deliverables and test scheduling