Nivratti Deshpande
Pune
Summary
- Holds 10+ years of experience in MES domain.
- Expertise in various MES systems, majorly into Rockwell Automation's FactoryTalk ProductionCentre (FTPC), FactoryTalk PharmaSuite (FTPS), POMSnet and Savigent
- MES and Non MES systems.
- IoT 4.0 solutions, Compatibility of AI and GEN AI Solutions
- Experienced and specialist in Recipe & Workflow Designing, MES-SAP Integration, Historian, OPC, Electronic Batch Record (EBR), Electronic Master Batch Record (eMBR) Authoring, Weighing and Dispensing (W&D)
- Strong understanding of Software Development Life Cycle as well as Software Testing Life Cycle.
- Involved in all Requirement Gathering, Business Specifications and translating those into different tangible deliverables such as Functional Specifications.
- Involved in Project Requirement Analysis, Functional Design which involves Functional Specification Authoring, Creating and Authoring Test scenarios, Designing complex Master Recipes, Validation Testing, Quality Management.
- Exposure of working on shop-floor with client and conduct functional and technical for operators
- Good knowledge of FDA 21 CFR Part 11, EU Annexure-11, GAMP 5 and GxP (GMP, GDP, GCP, GLP) standards
- Knowledge of Pharmaceutical Validation Environment, Computer System Validation (CSV), GAMP 5 Model, ISA-88, ISA-95 standard, FDA Regulation, GMP Standard, 21 CFR Part11, Pharmaceutical Manufacturing operation/Process.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Associate Project
Cognizant Technology Services
Pune
11.2021 - Current
Senior Functional Consultant
Rockwell Automation
Pune
09.2015 - 10.2021
Education
BE - Electrical And Electronics
Radharaman Engineering College
Bhopal06-2014
HSC - Science Education
Kendriya Vidhyalaya Sarni
Sarni06-2010
SSC -
Kendriya Vidhyalaya Sarni
Sarni06-2008
Skills
- Recipe Authoring and Testing Building Blocks
- Handson experience in Savigent
- Project Documents Authoring and Review
- Understanding of GDP Compliance
- Test Documents Authoring and Execution
- TrackWise (MS Excel)
- Functional knowledge of OSD and Vaccine production
- Skilled in Authoring Validation Documents Master Data Configuration
- Go-Live support
- SAP / ERP / Oracle Integration to MES
- Rockwell FactoryTalk PharmaSuite (FTPS) MES / SAP Integration (Functional)
- Weighing and Dispensing (W&D) and EBR Validation
- Authoring Requirements Traceability Matrix and Fit Gap Analysis
- Managing access management for FTPS
- Import and Export of FTPS components along with supporting data
- Computer System Validation (CSV)
- Provide support for shop floor activities in terms of FTPS use
- Warehouse Management System
- Performance Management
- JIRA tracking tool
- Expertise in Rockwell Automation FactoryTalk PharmaSuite (FTPS)
- Good functional knowledge of Injectable and OSD manufacturing & Packaging activities
- Recipe & Workflow Designing
- MES-SAP Integration
- Historian
- OPC
- Electronic Batch Record (EBR)
- Electronic Master Batch Record (eMBR) Authoring
- Granulation
- Compression
- Packaging
- ERP-Shop Floor Integration & XML/XPath
- B2MML
- Equipment Management
- GAMP
- Strong understanding of Software Development Life Cycle
- Software Testing Life Cycle
- User interaction
- Shop floor management user Requirements creation
- Execution test protocols (FRS, IT, IQ, OQ, PQ)
Certification
- MATLAB Basic certification.
- Workshop on Machine design, transformer and generators from Satpura thermal power plant.
- PLC Scada certification.
- Software testing certification.
- PSM 1, Project management Udemy courses.
Projects
- Zydus, SEZ (Cadila pharma), Validation for Manufacturing Packaging & Automation (Oral Solids). Validation of packaging recipes and EBR.
- Zydus, Moraya (Cadila pharma), Manufacturing Packaging & Automation (Oral Solids). Validation of Weigh & Dispense & EBR phase. Automation- Historian and OPC integration, Validation.
- Mylan, Weighing & Dispense. FDS authoring, Validation.
- Valenta Pharm, Weighing & Dispense, SAP-MES Integration, Performance management, OQ. Requirement gathering, FDS authoring, OQ protocol authoring and execution on site. Internal validation lead. Basic workflow designing; Room cleaning & Scale test/Calibration. Performance management software validation and installation on client side. EBR requirement gathering is ongoing.
- DRL, Weighing & Dispense, FAT. FDS and FAT authoring, OQ & PQ.
- Roche, FAT and Integration Testing.
- POMSnet , Worked as Support team Lead.
- 3M, QA for Workflow and Support team and leading the support team.
Languages
Hindi
First Language
English
Upper Intermediate (B2)
B2
Marathi
Intermediate (B1)
B1
Timeline
Senior Associate Project
Cognizant Technology Services
11.2021 - Current
Senior Functional Consultant
Rockwell Automation
09.2015 - 10.2021
BE - Electrical And Electronics
Radharaman Engineering College
HSC - Science Education
Kendriya Vidhyalaya Sarni
SSC -
Kendriya Vidhyalaya Sarni
Similar Profiles
Prateek BhardwajPrateek Bhardwaj
Senior Associate Project Lead at Cognizant Technology ServicesSenior Associate Project Lead at Cognizant Technology Services
Anuradha MallickAnuradha Mallick
Manager - Projects at Cognizant Technology ServicesManager - Projects at Cognizant Technology Services
Antony AbrahamAntony Abraham
Account Manager at Cognizant Technology ServicesAccount Manager at Cognizant Technology Services
Paras RajParas Raj
IT Analyst at Cognizant Technology ServicesIT Analyst at Cognizant Technology Services
Niraj DigheNiraj Dighe
Lead Software Engineer at Cloud Software GroupLead Software Engineer at Cloud Software Group