Parag Dave Email & Phone Number

Tokyo, Jp

As part of Site leadership team leading Digital Transformation programs for Manufacturing, Operations and Enterprise.Plasma Derived Therapy operations digitalization, technology deployment, infrastructure, network and cybersecurity operations management.Lab operations digitization, with deployment and management of various technologies such as LIMS, Lab Automation.Manufacturing Digitization with MES, Data Historian, Data lake. Site operations optimization with strategic digital initiatives and participation in leadership direction.

Jersey City, Nj, Us

I have taken on leadership roles focused on delivering transformative solutions within the pharmaceutical and biotech manufacturing sector. As a leader of the Solution Architect team, I have orchestrated the deployment of SaaS solutions tailored to clinical and commercial operations, driving digitalization across manufacturing and compliance domains.Strategic Leadership: I am overseeing end-to-end deployment and system integration, ensuring product and process maturity. My efforts encompassed fostering internal and external partnerships to enhance customer success.Product Development: Mentoring deployment teams in MES system application functions, compliance design, and multi-site deployments.Technical Leadership: I led integration design, validation, and deployment for MES systems using No-Code, Connector, and Custom integration development. Collaborating with System Integrators, I ensured custom-defined deliveries.System Architecture and Infrastructure: I provided technical and functional leadership, defining software, deployment, and infrastructure architectures. I developed SaaS and PaaS models with custom configurations.Program Delivery: My leadership was integral in deploying MES systems, integrating with ERP and Level 3 systems. I maintained a Quality First approach, upholding data integrity and compliance with 21 CFR P11, ALCOA+, GAMP, and cGxP standards.Program Management: I managed CAPEX/OPEX budgets, conducted strategic analyses, designed project architectures, and developed project support teams, resulting in enhanced ROI and project success.Strategic Architecting: Design of GxP systems, Automation, and Operations Technology roadmaps, aligning with Industry 4.0 principles to ensure compliance, sustainability, and integrated application architecture.People Leadership: As a leader of Solution Architects, I emphasized individual and technical mentorship, fostering leadership development, and facilitating external training opportunities.

Pittsburgh, Pennsylvania, Us

Global MES solution rollout and Management: Mylan global MES application solution and implementation of the best practices for manufacturing IT systems. Integration strategy with ERP, Automation, and other Mfg. systems, coordination between manufacturing sites. IT Strategy for successful solution functional and technical. Define and support Automation roadmap for the future growth and opportunity, the orchestration of multi-project environment to optimized delivery at least possible effect to an ongoing manufacturing business.Technical: IT Infrastructure management and strategic development for MES, Data Historian solutions, best practice implementation, disaster recovery plan assessment, and business impact assessment. Data Historian and SCADA system design, development and implementation. Strategic decision making for, optimized business process design with automation strategy towards review by exception.Functional: Business Process Development, optimization of the current business process, strategic partnership within the site to optimize manufacturing and gain excellence in automated manufacturing. SME consultation for Computer system validation for automation and manufacturing IT systems. Change control review for application and business process changes and all scope project delivery.Finance and Management: Vendor selection strategy, Vendor Engagement, and Negotiations, ROI Analysis, Feasibility study, Business Risk assessment. Program Management, Project Portfolio Management, forecasting of the project, CAPEX, and OPEX run sheet deliveries for governance. Achievements: Program Owner of Automation program in Morgantown, WV site. - $8 Million Site Equipment Upgrade, making production floor technology ready.- $700K Data Historian Implementation sitewide. Saving of production cost up to 20% per batch.- $1.8 Million Sitewide MES implementation. Reduction of cycle time up to 30% with technology, execution of Electronic Batch record process.

Hamburg, Hamburg, De

Werum IT Solution is one of the very well know and leading MES solution provider to global clientele specifically in Pharmaceutical, Biotech, Medical Device and Consumer goods industry that regulated by FDA regulations. Technical support and consulting: MES (Manufacturing Execution System) for Pharmaceutical, Biotech, Medical device manufacturing and related business process clients. Development and deployment of PAS-X MES Software. Overall project management, Validation planning, Disaster Recovery Planning, over all IT infrastructure design and management. Responsibilities and Duties:Project management, Return on investment (ROI) analysis for new projects, project support activities. Process development consultation, Master Batch Record (MBR) development, PAS-X installation, technical support. IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Process Qualification) testing and validation process development and management.Fit analysis for new projects, proof of concept development, customer requirement analysis and development of the demo system. Communicate client expectation with senior management for project support and schedule. Consultation for industrial expertise in enforcing cGxP quality standard and complains with authority. Development and selection of the COTS and SaaS systems with internal and external vendor meetings and scope development and over all project management with SOX compliance. Support and management of service desk for general support ticket and hyper-care tickets.Knowledge development and mentoring new employees.

Newark, Nj, Us

Website development at School of management. Job board development, data analysis and bench-marking of Department with other universities. Archive data knowledge management database development at Graduate Studies office. Policy development, operations procedure development for NJIT operations handled by Graduate Studies Office. BS/MS program promotion at NJIT. Back office administration support to Graduate Studies office staff. Event management, document management and meeting scheduling.

Waldkirch, De

Vision (3D) camera, Smart Camera, Photo electric sensors product development. Product application support and software development, real-time software application, firmware development for communication with PLC, DCS system. Software development and code review. Electrical and design QA/QC as per the NEMA and UL licencing for the food and beverages industry. System architecture design, development ,sales and support for the control system in food and beverages industry (Production), Supply chain control (Wear house, automated sorting of mail, packages, carton). Project Management: Junior level project management, project scheduling, time budgeting, work load and recourse allocation. Presentation to higher management, customer relation and support. Part of the research team to understand the customer need and application development.

Milpitas, California, Us

Web application and Software Development. Integration, migration, modification of the existing applications and projects. Code review and code generation, mock-ups design. Development with HTML5, CSS3, MySQL, Javascript. Automation QA development with selenium, and visual studio team suite.

Development of the project as described below, Production work and testing of final product and ensure quality of the product. Design, implementation, hardware implementation, memcatch with membase clustering and troubleshooting malfunctioned system. Design, development and implementation of social network website.Test and debug the newly implemented, existing code. Enhance and maintain the existing applications.Working as technical support for the business, operations and QA. Also working as QA as unit check of the applications.Involved in production support, planning, mockup design, building a mockup application for testing, business logic.Used AJAX, JavaScript, J Query, CSS, HTML, MySQL, PHP and CAKE PHP to create web interfaces. Sencha, EXT JS for mobile interfaceUsed Object Oriented Programming concepts to develop the functionality in all the project assemblies and code behind pages. Creation of functional specifications and documentation for the newly created applications.From designing the ER diagram to reveres engineering to design the schema also, identify and optimize long running SQL queries. Use of stored procedure.

Correlates faculty and students of the class, to manage the flawless study and student can work and study without any difficulty or confusion. My work as describe below is particularly to manage the relations between faculty and student. Assisted to design the software using C#. To generate the student GPA and grading system that connected with the database.Design the one tool of the software that keep watch on the attendance of the student and notify if in condition of leak attendance.Assisted with development of database schemas for student information datasets.Assisted with programming of software to interact with student information databases using SQL, HTML, and various scripting languages on Windows.Distribute the Notice and massages given by the Professor, enforce regularity and timeliness.Manage the class Schedule give support to design the schedule for the exams and quizzes Help to solve student's primary level problems with administration and IT related.Represent the student body to the faculty members and school as I am part of SGA (Student Government Association).Worked As Electronics and IT Engineer (Development)

Development of the different project as described below, Production work and testing of final product and ensure quality of the product. Design, implementation and troubleshooting malfunctioned system. Worked with the project development on the ARM (ARM9 TI) and PSoC (PSoC3 and PSoC5 Cypress Semiconductor). Development of the sensor based system with data logger and interface between physical board and computer. Also worked with 8051 microcontroller for design system with assembly language and C++. Design, development and implementation of customer and customer service client websites for Akashganga Electronics.Test and debug the newly implemented, existing websites. Enhance and maintain the existing applications.Providing technical support for the customer service, operations and QA.Involved in production support.Used AJAX, JavaScript, HTML, MS SQL and C# to create web interfaces.Used Object Oriented Programming concepts to develop the functionality in all the project assemblies and code behind pages. Creation of functional specifications and documentation for the newly created applications.Identify and optimize long running SQL queries. Use of stored procedure.Total counting and smart card readers for the calculating the amount of milk collected and price. Part of the team to design software for this product. PCB design and check the functional circuitry for the operation.Worked As Electronics and Instrumentation Engineer

In

Worked in the research subject in the semiconductor design and thin-film development. Working experience with sputtering system (Magnetron), PVD (Physical vapor deposition), EBPVD (Electron beam PVD), XRD (X-Ray diffraction), wet Etching. Developing thin-film capacitor (Silver with glass substrate and insulator) and resistor (TaN Tantalum Nitride). Testing diffrent electrical and physical characteristics with changing shapes, thickness, different metal connection. With EBPVD and PVD produce MFIS FET (Metal ferro electric insulator semiconductor) with Pb(Zr,Ti)O3 with SiO2 as buffer layer. Testing the electrical and physical characteristics of the FET. Research as based on to get minimum leakage current at the FET. In this process also used wet etching for the create the layers and grooves. Design the masks for the operations. Used the XRD, SEM also TEM (Scanning and Tunneling Electron Microscope) for the surface characterization. Also have troubleshooting knowledge of the semiconductor instrument worked with different vacuum pumps and gauges.

Master Of Business Administration (Mba), Management Information Systems, General

Master’S Degree, Computer Science

Master Of Science (M.Sc.), Electronics

Bachelor Of Science (B.Sc.), Instrumentation

Diploma, Electrical Engineering