ABHIJEET AMBADAS HANGE.
Experience in conducting statistical analysis and Time/Motion studies analysis to aid in process improvement.
Experience in manufacturing process like web converting, extrusion, etc.
Experience in applying process engineering techniques and continuous improvement tools like Six Sigma (DMAIC) and Lean Manufacturing to optimize industrial systems.
High Skills and experience in implementing IE techniques like Economic/ cost analysis, time and motion studies, and production and inventory control.
Experience in Risk Management System, Root Cause analysis, FMEA methods for Engineering Design, and resolving Non-conformances and/or Deviations.
Extensive experience in Validation system documentation like IQ/OQ/ PQ protocols, Summary Reports, Deviation Report, Corrective and Preventive Action (CAPA), Change Controls, User requirements document, Standard Operating Procedures (SOPs), Validation Plan.
Experience in reviewing and maintaining the Calibration certificates, log books, batch records, Preventive Maintenance Procedures, Turn over Packages (TOP).
Experience in understanding the P&ID, mechanical and electrical drawings.
Experience in working with Lab Equipment like Incubators, Refrigerators, Cold-rooms, Autoclave HPLC, Laminar Flow Hood, and Particle Counter.
Performed Process Equipment and utilities Validation for Temperature controlled unit and HVAC system.
Performed Temperature Mapping for Various equipment using Kaye Validator AVS, Kaye 2000, Kaye ValProbe and Ellab Dataloggers.
Proficient with Microsoft Word, Excel, and PowerPoint, with excellent documentation and technical writing skills. Authors SOPs, validation protocols and reports. Ability to work within teams of multi-disciplinary groups and experience working in international regulated pharmaceutical environments.
Experience and knowledge in cGMPs, cGXPs, PICS regulations, FDA regulations (21 CFR 211, 210, 11), and EU Annex 11.
Tools: MINITAB, MATLAB, Python, SQL server, Tableau, MS Excel, MS Office, AUTOCAD, Solid works, ANSYS.
Concepts & Skills: FMEA, Root Cause Analysis, Lean Six Sigma, ISO 14001, ISO/IATF 16949, ISO 13485, ISO 14644, ISO 9001, ISO 17025, 8D-Problem solving, Continuous improvement, Forecasting, Scheduling, Data Reporting, Data Mining & Analytics.
Certifications: Certified Six Sigma Green Belt, American Society for Quality.
CEVA Biomune, Lenexa, Kansas
Industrial Validation Engineer SEP’19- JUN’20
Performed Time/ Motion studies analysis for Filling Processes.
Experienced in planning and implementing lean manufacturing principles like material presentation, single piece flow, etc.
Responsible for monitoring and planning up the manufacturing and logistic process.
Worked with production team to provide efficient flow system.
Performed and Assisted in Engineering Economy analysis for capital expenditure projects.
Implemented manufacturing processes using statistical analysis to manage, execute, and complete projects that increased productivity, improve quality or eliminate non-value-added process steps.
Experienced in preforming Gage R&R studies, Finding Process capabilities using MINITAB.
Conducted Process FMEA’s in manufacturing environments to identify all types of contamination in clean room production area, to reduce environmental contamination and improve product quality.
Experienced in working in warehouse and documenting reports like capacity utilization, waste and rework, etc.
Experienced in generating SPC (statistical process control) charts and its analysis to study process changes with respect to time and thus helping to reduce unpredictability of variation in process.
Authored and executed IQ, OQ, PQ, and TMV protocols for process validation for Filling process.
Prepared and executed validation documents such as installation qualification protocols, operational qualification protocols, installation and operational qualification protocols, requalification protocols, User Requirement specification documents, design qualification documents, impact assessments and development protocols using GDP for QC laboratory equipment, process equipment’s and Utilities in compliance with Validation Master Plan.
Authored User Requirement Specification documents for QC laboratory equipment like Controlled Temperature Units and Autoclave.
Provided technical inputs to process deviation and implemented Corrective and Preventive Action (CAPA) to prevent re-occurrence.
Prepared and Executed Engineering Study for SIP (Steam in Place) and PQ protocol for SIP for Batching Area to Validate Sterilizing of large Tanks and Filling Line.
Provided process validation oversight to ensure adequacy of validation activities and documentations in terms of regulatory compliance.
Worked in Coordination with various Department like Manufacturing, QA, QC and QAD for Validation aspect.
Velocity org., Pune, India
Sales Engineer Lead FEB’15 – NOV’16
Led and managed a team of 12 people and performed mentorship duties to enhance their marketing skills.
Assigned sales target and provided guidance to team members to achieve the goals.
Used Microsoft SQL server 2008 to develop Ad-hoc sales and marketing reports
Used Tableau and Microsoft Excel for data visualization to create charts and dashboards for presentations.
Awarded the best sales and leadership awards for leading the team and increasing the team sales.
ONGC, Sivasagar, India
Mechanical Engineering Intern NOV’13 –DEC’13
Maintained and worked on 6-cylinder and 12-cylinder diesel generator sets and provided daily reports of OEE.
Supervised and trained team during maintenance of generator sets insuring safety and quality of maintenance.
Conducted wrench time studies on the workers conducting maintenance of generator sets.
Implemented 5-S at the workplace to keep the workshop organized.
Created process document for diesel shop warehouse for maintenance and quality control.
Design of Experiments
Controlled influential factors of pH level in black tea using Analysis of Variance (ANOVA) in SAS.
Performed preliminary analysis, factor effects comparison and contrasts with significance level of 0.99.
Data Mining & Analytics
Completed project on bank note authentication using data mining and analytics.
Identified counterfeit bank notes for University of Applied Science Ostwestfalen-Lippe dataset using MATLAB.
Performed feature visualization, normality & model classification to attain accuracy of 0.98 in Python.
The analysis used in this project was helpful in generating an output that counterfeit banknotes can be distinguished from genuine banknotes.
Quality Control Using Six-Sigma
Conducted Six sigma project on Fivecaion pharmaceuticals for manufacturing of bottles.
Used DMAIC methodology to the manufacturing of bottles, hence improving manufacturing process by decreasing defects and saving up to $2.5 million per year.
Conducted FMEA to document current risks and failures and understand that the major issue was change in diameter and change in height of the bottle.
Created pareto chart using Microsoft Excel to identify the major causes which needed to be addressed.
Found, out of control process by making control charts using Microsoft Excel and tried to improve the process by brainstorming.
Created process document to control the process and to help the employees to work accordingly.
Multiple Linear Regression Analysis
Analyzed dependence of fuel economy of various cars, with respect to horsepower, weight, acceleration and number cylinders.
Used SAS to create the ANOVA table and scatter plots and partial scatter plots.
Removed multicollinearity, used Model search to find the best potential model.
All inferences were carried out on the selected final model to find confidence interval & prediction interval.
Time study project
Conducted a time study analysis for local restaurant in UTA campus.
Picked the starting point as the kitchen to understand the flow of service and recorded how the employees completed their task.
Created a Value Stream Map for the process.
Conducted analysis using Microsoft Excel and reported the necessary changes that can help in improving effectiveness of the process.
M.S. in Industrial Engineering, The University of Texas at Arlington GPA 3.5 AUG’17 – MAY’19
Quality control, Metrics and Measurement, Operations Management (SAP), Design of Experiments, Data Mining and Analytics, Decision Analysis, Applied Regression analysis, Operations Research, Statistics.
BE in Mechanical Engineering, Savitribai Phule University, Pune. GPA 3.0/4 AUG’10 – MAY’14