Shrinivas Bhosale

About Shrinivas Bhosale

Biomedical Engineer with experience working as a LIMS analyst in both R&D as well as processing. Experienced in gathering requirements, designing, configuring and supporting Perkin Elmer LIMS system and Thermo SampleManager LIMS. Assisted in mapping requirements for quality related processes like CAPA and root cause analysis. Experience working with SPC and software’s like LIMS, analyzing LIMS data. Knowledge and skill in applying regulatory methods in compliance with GLP, GMP and 21CFR Part11 backed by good and consistent academic performances. Ability to gather information, analyzes, compile and interpret useful data.LIMS program analyst and developing LIMS methods for Micro, Chemical and Analytical labsRequirement gathering, designing, and configuring LIMS data, user documentation, user training.Experience with management and tracking of analytical data in support of pharmaceutical products working with Perkin Elmer LIMS/ELN or electronic data management systems.Experience configuring LIMS methods i.e. Sample methods and test methodsVerification of test results and making sure data is tracked and archived in a timely manner.Experience working with coplex LES forms and configuring sample templates and test templates.Knowledge of Validation master plan (IQ, OQ, PQ, RQ), RTM, Validation summary report, GAMPV.GCP, GLP and GMP protocols, and 21CFR Part11, 210, 211 FDA compliance. Experience writing SOP, Cleaning Procedure, Analytical Methods and its Validation protocols and reports.Verification/Maintenance of equipment files and documentation within AD and ability to work with QA in completing tasksExperienced in working with software like C/C++, java, Matlab, C#, ASP.NET, SQL, Oracle. Experienced working in clinical environment and good understanding of medial terminologies, statistical theory and methodologies. Ability to work on multiple projects in a fast pace environment

Experience

1. Sr Lims Developer and Analyst

   Labtopia, Inc.

   Apr 2018 — Present · Houston, TX, US

   Serve as Product Owner for LIMSView, driving product vision through well-defined user stories, main frame design, and an extensible integration framework.Designed and developed the SampleManager integration layer for LIMSView, enabling seamless system interoperability.Led SampleManager (v21.1) implementation for the Capital Region District, ensuring on-time delivery and alignment with business requirements.Successfully executed SampleManager upgrades to v21.3 for enterprise customers including City of Newport News, MGC Pure Chemicals, ASTM (American Society for Testing and Materials), and Keurig Dr Pepper Snapple.Played a key role in requirements gathering, Requirements Traceability Matrix (RTM) creation, and project planning for Sibanye-Stillwater Mining, supporting structured and compliant delivery.Delivered bi-directional instrument integrations for clients such as City of Newport News and Dr Pepper, improving automation, data accuracy, and operational efficiency.

Education

• Savitribai Phule Pune University

  Bachelors of Engineering, Information Technology

  2006 — 2009

• University of Bridgeport

  Master's degree, Bioengineering and Biomedical Engineering

  2010 — 2012

• Maharashtra State board of technical education

  Diploma, Information Technology

  2003 — 2006

Skills

• Rational Rose Enterprise Edition
• Informatica
• C#
• Microsoft Sql Server
• Business Analysis
• Turbo C++
• Irise
• Matlab
• Visio
• Asp.net
• Turbo C
• Lims