Summary
Overview
Work History
Education
Skills
Timeline
Generic

Nidhi Patel

1005 Grayson Dr Souderton,PA

Summary

Result oriented engineer with more than 6 years of experience in pharmaceutical industries and manufacturing industries. In depth knowledge of validating pharmaceutical equipment s through Clean in Place and Sterilization in Place, Quality tools, Lean, Six Sigma. Managed and inspected manufacturing assembly line. Experience in working with cross functional team environment. Lead and managed various projects within stipulated timeline.

Overview

11
11
years of professional experience

Work History

Validation Engineer II

Hyde Engineering + Consulting (Merck west Point) C
West Point, PA
08.2019 - Current
  • Author, Review and approve protocols, standard operating procedures (SOP), reports, implement corrective actions, and data analysis reports for validation projects
  • Analyzed and optimized operations, providing input on standard procedures and policies to streamline throughput
  • We validated Lyophilized vaccine equipment, including Liquid nitrogen tunnels
  • Executed initial validation and periodic re-validation of Sterilize-In-Place (SIP) and Clean-In-Place (CIP) and Clinical Trial Unit (CTU) of pharmaceutical equipment, systems, autoclaves, and washers
  • Responsible for resolution of deviations, CAPAs, root cause analysis techniques during deviation investigational procedures
  • Employed Overall Equipment Effectiveness (OEE) and reduced performance loss
  • Supported 6+ projects like Pneumococcal polysaccharide, Lyophilization and Dengue vaccines requalification by serving 70+ deliveries in a fiscal year (both upstream and downstream)
  • Implemented new strategies in continuously improving the process flow in several validating procedure to cut down processing time and to increase efficiency.

Pharmacy Technician

Walmart Pharmacy Inc
Hetfield, PA
08.2013 - 12.2019
  • Responsible for the data entry of prescriptions, managing drug databases and records, filling prescriptions for patients with extreme care and maintaining strong communication with the entire staff to provide high quality patient care
  • Responsible for coordinating between the patient, physician, and insurance provider to establish payment and proper care
  • Communicated with patients in friendly manner when delivering routine vaccines, helping them understand what they were receiving and assisting the senior pharmacist in general pharmacy management.

Research Scientist

Bristol-Myers Squibb
Pennington, NJ
04.2018 - 08.2019
  • Fulfilled orders sent to different scientists through the operation of the liquid handling system (VSLH) by solubilizing compounds, transferring compounds via volatile solvent transfer (VST), and drying down compounds with a Genevac Drier
  • Solubilized compounds that are difficult to physically extract from the bottle
  • Familiar with Production shipping Sending samples to the scientist or other members of compound management using TQM(TaskQmanage)
  • Provided technical support during presentations of project progress at internal meetings or external events
  • Participated in conferences and seminars related to research science topics
  • Recorded and reported test results, performing calculations, producing graphical solutions and representations.

Capstone Research Internship

Temple University
Philadelphia, PA
09.2016 - 04.2017
  • Conducted independent research, investigating the Barriers and Facilitators affecting the Recognition, Reporting, and Resolution of Foods and Drugs Post-Marketing incidents
  • Provided a brief introduction about the FDA, the roles of drug manufacturing and food processing companies in ensuring the safety of their products to the consumers & the roles of food and Drug return/recall policies for effective post marketing incidents resolution.

Education

Master’s Bioinnovation -

Temple University
Philadelphia, PA
05.2017

Bachelor’s Life Science -

Pennsylvania State University
Abington, PA
05.2013

Skills

  • Excellent analytical and problem-solving
  • Communication and interpersonal
  • FDA Regulations and Guidance
  • GMP
  • GCP
  • GLP
  • HACCP
  • 21CFR
  • Global Regulation Requirements
  • SAP
  • PAS-X
  • GLIMs
  • Xpertval60
  • Compliance wire
  • Microsoft Office and Visio
  • COSMOS
  • Track wise
  • Kneat
  • ProCal

Timeline

Validation Engineer II

Hyde Engineering + Consulting (Merck west Point) C
08.2019 - Current

Research Scientist

Bristol-Myers Squibb
04.2018 - 08.2019

Capstone Research Internship

Temple University
09.2016 - 04.2017

Pharmacy Technician

Walmart Pharmacy Inc
08.2013 - 12.2019

Master’s Bioinnovation -

Temple University

Bachelor’s Life Science -

Pennsylvania State University

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Nidhi Patel