Manufacturing/Industrial Engineer with 2+ years of experience with Manufacturing & Pharmaceutical industry. Have knowledge and experience of rapid prototyping, designing manufacturing process, documenting the Production Part Approval Process (PPAP), Process Failure Mode Effects Analysis (PFMEA) and control plans for manufacturing equipment.
Experience of designing products and manufacturing assembly line using ProE Creo/AutoCAD
Experience in executing cleanroom validation & qualification protocols (IQ, OQ, PQ) according to cGMP and FDA regulations (21 CFR).
Working Knowledge of problem-solving techniques including 8D, root cause analysis, and 5 Whys. Also, experience in handling CAPA reports.
Skilled in conducting Statistical Process Control (SPC) for critical parts.
Hands-on experience with lean manufacturing tools such as- 5S, Kaizen, PDCA, and TQM.
Working knowledge of 7 Quality Tools- Ishikawa, Check Sheet, Control and Pareto Charts, Histogram, Scatter Diagram, Flowcharts.
Internship at FireEye, Inc. exposed me to different aspects of Program Management: Managing SKU configuration, manufacturing quality, Hardware testing, the Setup process for EOL, process improvement, data analysis for generating metrics every week. Overall, the training gave me a basic understanding of Program management.
Certification: Six Sigma Green Belt & AutoCAD.
In addition to undergraduate courses and projects in Bachelors in Mechanical Engineering at Gujarat technological University, the graduate courses of Masters in Industrial Engineering at San Jose State University undertaken by me including - Manufacturing Engineering I & II, Operations Planning and Control, Supply Chain Management, Lean Six Sigma have expanded my horizon in Operations and Supply chain/Logistics domain.
Experience with SAP ERP, Python, R Language, SPSS.
If you believe that my experience and skills can add value to your organization, I would be happy to connect with you and discuss potential opportunities.
I can be reached on alaymahadkar@outlook.com