Vivek P.

Vivek P.

EMT First Responder

Followers of Vivek P.1000 followers
location of Vivek P.Raleigh, North Carolina, United States

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  • Timeline

  • About me

    Engineering Systems Validation & Doc Control

  • Education

    • Rutgers School of Engineering

      2015 - 2019
      Bachelor's degree Biomedical/Medical Engineering

      Activities and Societies: Rutgers University Habitat for Humanity Physics Department Learning Assistant Program EMT First Responder Rutgers University Habitat for Humanity: Builds Director/Volunteer Manager Rutgers University School of EngineeringDepartment of Biomedical EngineeringBiomechanics and Rehabilitation track

    • Rutgers University–New Brunswick

      2019 - 2021
      Master of Engineering - MEng Biomedical/Medical Engineering 3.6 GPA

      Certificate: Medical Device Design & DevelopmentDegree project: 40pg medical device proposal w/sample patent, 510k summary, and business planSummary: Completed coursework in medical device design & development and wrote a 40pg medical device proposal consisting of patent draft and business plan for anticoagulative ECMO tubing. Gained experience in medical device design & development, patent application & IP protection, regulatory clearance pathways, FDA, ISO, ASTM, OEM-CMO tech… Show more Certificate: Medical Device Design & DevelopmentDegree project: 40pg medical device proposal w/sample patent, 510k summary, and business planSummary: Completed coursework in medical device design & development and wrote a 40pg medical device proposal consisting of patent draft and business plan for anticoagulative ECMO tubing. Gained experience in medical device design & development, patent application & IP protection, regulatory clearance pathways, FDA, ISO, ASTM, OEM-CMO tech transfer, and market research. Show less

  • Experience

    • Highland Park First Aid Squad

      Aug 2014 - Dec 2017
      EMT First Responder

      •Respond to 911 calls during weekly 8hr overnight shifts•Administer BLS care pursuant to NJ EMT license •Remain calm and maintain a professional attitude•Work cooperatively with the crew to fulfill patient care needs •Effectively manage first responder crews on calls

    • Habitat for Humanity

      Sept 2016 - May 2019
      Builds/Project Manager for Habitat for Humanity

      -Overhauled volunteer registration process by integrating automate.io & Google cloud-based apps (Docs, Sheets, Forms). -Raised $20,000+/year during 2-year executive board term to maintain yearly sponsorship contracts with South Plainfield Habitat for Humanity.-Coordinated budgetary, lodging, transportation, meals, and itinerary logistics for out of state service trips and Build-A-Thon charity construction competitions.

    • Rutgers University, Department of Physics & Astronomy

      Sept 2017 - May 2019
      Undergraduate Learning Assistant

      •Instruct 30+ size undergraduate Physics 1&2 recitations•Trained students to master their metacognitive skills by developing effectivelearning habits•Weekly module previews with course administrators and TAs to review learning objectives

    • Rutgers University

      Sept 2018 - Oct 2022

      Supervised call center, testing centers, and PCR kit packaging department.Coordinated with staff from Rutgers EHS, Office of IT, and Student Health centers to drive University testing & vaccination objectives.Designed & commissioned automated PCR test tracking process to link specimen serial number to patient Rutgers ID. Resolved specimen processing bottleneck and reduced processing times by 60%.Designed & commissioned PCR test kit packaging process to automate inventory tracking; weekly production increased 3-fold.Monitored and troubleshoot PCR kit vending machines and online vending portal for jams, card swipe module errors, RUID card misreads/rejections, 3G signal issues. Show less

      • 3D Printing Specialist

        May 2021 - Oct 2022
      • COVID-19 Operations Supervisor

        Jan 2021 - Oct 2022
      • EMT First Responder

        Sept 2018 - Jan 2021
    • DePuy Synthes

      May 2019 - Aug 2019
      Validation Engineer Intern

      Coordinated w/R&D, Validation, and Quality to complete projects in a ISO 13485 regulated environment.Designed packaging process for Prosidyan Inc. trademarked Fibergraft product line.Completed process validation projects: authored IOP-Q, WI, SOPs, and PM plans for Bosch Doboy B550M Pouch Sealer, Belco B550M Tray Sealer, and Terra Universal ISO-7 clean-room.Conducted engineering studies for optimal sealing parameters and development of packaging process - used guidance from ASTM F1886, F1929, F88.Lead services from Bioburden testing, HVAC, Plumbing, and Electrical contractors related to project work orders. Show less

    • Gill's Process Control, Inc.

      Oct 2022 - Dec 2023
      Validation Specialist

      Lead QTS Trackwise change controls to ensure alignment of CQV packages’ impact assessments and action items with site Quality and project timeline requirements.Utilize EAMS database to analyze asset maintenance, equipment parts, calibration records to identify revisions, deletion, and/or additions to PM schedules.Work with process engineering, validation, quality, automation, calibration, biological & chemical lab, and EHS departments to ensure on time delivery of CQV Packages.Assist site staff with CAPA, FMEA reports and deviation investigations to determine root cause, implement corrective actions, and determine asset/product disposition.Automation: Serialization retrofit for finishing line, Commissioning & OQ of FANUC robotic palletizer, Allen-Bradley PLC/HMIs, generation of design specification, alarm assessment, equipment & computer classification assessment documents. Commissioning/Decommissioning: Aseptic, terminal, and non-sterilized manufacturing line equipment, Environmental monitoring systems, autoclaves, MECO Steam distillation units, lab equipment, filling/finishing equipment.Qualification of GMP/Non-GMP Plant utilities: Pharmaceutical water & steam systems, gasses.Warehouse CQV: Temperature Mapping Engineering Study & IOQ for client emergency warehouse requirement.Facility/HVAC CQV: Aseptic line decommissioning & ISO 7,8 Facility requalification to ISO 5 Aseptic commodities storage facility. Show less

    • FUJIFILM Diosynth Biotechnologies

      Jun 2024 - now
      Engineering Document Controller
  • Licenses & Certifications

    • You Need a Career Development Plan

      LinkedIn
      Sept 2025
      View certificate certificate
    • Project Management Foundations

      LinkedIn
      Sept 2025
      View certificate certificate
    • OSHA 30 Hr General Industry

      US DEPARTMENT OF LABOR OSHA
    • NJ EMT

      NJ Department of Health
    • Cybersecurity Awareness: Cybersecurity Terminology

      LinkedIn
      Sept 2025
      View certificate certificate
  • Volunteer Experience

    • Kitchen Assistant and Waste Disposal

      Issued by Elijah's Promise on Mar 2015
      Elijah's PromiseAssociated with Vivek P.
    • Reading Coach

      Issued by Highland Park Public Library on Jun 2014
      Highland Park Public LibraryAssociated with Vivek P.