Engineering Assistant

Digvijay Shinde

Phone:203-***-****

Email: ***************@*******.***

An engineering professional with experience within medical device industry and pharmaceutical manufacturing settings coupled with demonstrated passion for identifying complex problems and reviewing related information to develop and evaluate options and implement solution. Diverse experience in additive manufacturing, technical support and research. Working knowledge of cGMP, incident management with CAPA guidelines. Driven, energetic and known as excellent problem-solver and a professional with proven ability to hit the ground running and take the initiate in a collaborative team environment. Unique combination of skill from biotechnology and biomedical engineering recently implemented to build a 3D printer for selectively permeable bio-polymeric membrane: Nephron cell mimicking (Under U.S. process patent review).

AREA OF EXPERTIES

Process/design Validation and Verification regulations FDA/GMP Requirements

Incident management- CAPA guidelines 21 CRF Part 11

Documentation with International Standards Aseptic conditions/Clean room practice

Pro/Engineer & Solid edge Microbiological testing

Python programming with MySQL Databse Calibration and planned maintenance

Educational Background

Masters of Biomedical Engineering-University of Bridgeport, Jan 2016 - May 2018

Thesis: “Fabrication of 3d printer for membrane printing”

Advisor: Dr. Prabir Patra & Dr. Isaac Macwan.

Concentrations- Bioinformatics (Developing Python based applications), Digital Signal Processing, Nuclear Magnetic resonance -Image processing. Overall GPA-3.7/4.0

Bachelors in Biotechnology Engineering Visvesvaraya Technological University, Aug 2009 - June 2013

Successful completion of two final year projects with in Central governments state of the art facility (Food Journal 2013).

Concentrations- Genetic Engineering, Immunology, Bioinformatics- FASTA & BLAST applications, Molecular Biology and Biostatistics.

First class with Distinction engineering degree.

Professional Affiliations

Central Food Technological Research Institute: Research Assistant Jan 2013 – Nov 2013

-Research Assistant for Dr. N.K. Rastogi in Food Engineering Laboratory for development of rose petal pigment Anthocyanin as food colorant using forward osmosis.

-Process designing Lab to pilot scale.

-Designed forward osmosis module for maximum water flux across the membrane

-Statistically analyzed results from Mass spectroscopy and HPLC to interpret results.

-Achieved 16 Folds of rose color concentration. (Food Journal 2013).

Nirav Bio-solution: Technical Business Associate Jan 2014 - Sept 2014

-As Technical Business Associate researchers and doctors were introduced with novel state-of-the-art technologies in field of Life Science research for overall betterment of results.

-Technical engineering support for sales team and clients.

-Product report submission, detailed specifications for special product designing draft and validating.

-Calibration, troubleshooting and timely maintenance (TM) of supplied equipment’s and consumables at client site.

-Creating reports in case of failure or misfunctioning of equipment with international documentation standards.

Bristol-Myers Squibb: Subject matter expert May 2015 - Jan 2016

-Internal team of BMS was supported with computer and research software as a Subject Matter Point Person (SMPP).

-Lead a team of Tech Support Engineers, 92% resolution results on same level with minimal expeditions of tickets.

-Programmed Microsoft Win based softwares.

-Single handedly managed a project on Microsoft share point and collaborated with internal BMS and external Microsoft teams.

University of Bridgeport: Research Assistant Jan 2016 - Present

-A thin membrane with selective separation properties just like Kidney cells (Nephron mimicking) were printed using 3D printer.

-Custom built a 3D printer with duel extrusion nozzles.

-Programmed Arduino Mega 2560 chip in C# and Python programs to efficiently extruder polymer from both nozzles.

-Formal cGLP and hazardous training for students and researchers.

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