Summary
Overview
Work History
Education
Skills
Timeline
Generic

Nilay Patel

Lowell

Summary

Experienced professional with four years of expertise in manufacturing operations in pharmaceutical and medical device company, focusing on Active Pharmaceutical Ingredients (API) and Drug Substance (DS). Specialized in preparing media for cell growth, demonstrating proficiency in Current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and Aseptic techniques. Proven track record in ensuring compliance with industry standards and regulations while contributing to the efficient production of pharmaceutical components. Strong background in cultivating aseptic environments and executing protocols for the optimal growth of cells in a manufacturing setting.

Overview

10
10
years of professional experience

Work History

Manufacturing Technician/Group Lead

Cirtec Medical
04.2020 - Current
  • Practice and followed cGMP
  • Inspected finished products for quality and adherence to customer specifications
  • Performing in process inspection of CMM
  • Developed and maintained courteous and effective working relationships
  • Worked on KDF, SUSS, Top Coat, Base Coat
  • Trains for proficiency in the operation of primary production equipment within the assigned functional area (i.e
  • Bioreactors, chromatography skids, media or buffer preparation equipment etc.)
  • Performing shipping task from sales order to dispatching
  • Provided needed support to team leads and supervisors complete documentation
  • Kept production logs and maintained job material inventory
  • Leading team from the front, decision-making, coaching, mentoring, developing the team's skills and managing conflict
  • Working closely with supervisor on daily production goals, monitoring progress towards goals.

Production Operator

Rapid Micro Biosystem
05.2018 - 01.2020
  • Running and handling automatic machines in the cleanroom
  • Prepare a media solution for bacterial growth (Cell Culture)
  • Troubleshooting problems and errors on the automation machine
  • Calibration check on systec media
  • Practice and followed cGMP
  • Process document data through batch records
  • Worked on Systec media development
  • Final inception of cassettes and approved for packaging.

Food Associate Engineer

Sweety Industry
08.2014 - 11.2017
  • Replenished condiments, beverages, and supplies while maintaining the cleanliness of service areas
  • Audit of machine before production starts up
  • Checked completed orders for accuracy and bagged meals for easy carrying
  • Working with senior management to manage large and complex production tasks
  • Assisted management with inventory control and stock ordering
  • Reported non-conforming results and trends to supervisor for corrective action.

Education

Food Processing Technology -

DDIT Institute of Technology
Nadiad, GJ
05.2014

Business Management -

Carrick College
Sydney, NSW
08.2011

Skills

  • Cell Culture
  • Media preparation
  • Root Cause Analysis
  • Batch Records
  • Deviations
  • MS-WORD
  • Standard Operation Procedures (SOPs)
  • MS-EXCEL
  • Corrective Actions and Preventive Actions
  • Documentation Practice (CAPA)
  • Costumer Identification Programe(CIP)
  • Environmental Monitoring
  • Standard Operating Procedures
  • CGMP
  • Autoclave

Timeline

Manufacturing Technician/Group Lead

Cirtec Medical
04.2020 - Current

Production Operator

Rapid Micro Biosystem
05.2018 - 01.2020

Food Associate Engineer

Sweety Industry
08.2014 - 11.2017

Food Processing Technology -

DDIT Institute of Technology

Business Management -

Carrick College
Nilay Patel