
Vivek P.
EMT First Responder

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About me
Engineering Systems Validation & Doc Control
Education

Rutgers School of Engineering
2015 - 2019Bachelor's degree Biomedical/Medical EngineeringActivities 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 - 2021Master of Engineering - MEng Biomedical/Medical Engineering 3.6 GPACertificate: 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 2017EMT 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 2019Builds/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 2019Undergraduate 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 2022Supervised 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 2022COVID-19 Operations Supervisor
Jan 2021 - Oct 2022EMT First Responder
Sept 2018 - Jan 2021

DePuy Synthes
May 2019 - Aug 2019Validation Engineer InternCoordinated 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 2023Validation SpecialistLead 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 - nowEngineering Document Controller
Licenses & Certifications
- View certificate

You Need a Career Development Plan
LinkedInSept 2025 - View certificate

Project Management Foundations
LinkedInSept 2025 
OSHA 30 Hr General Industry
US DEPARTMENT OF LABOR OSHA
NJ EMT
NJ Department of Health- View certificate

Cybersecurity Awareness: Cybersecurity Terminology
LinkedInSept 2025
Volunteer Experience
Kitchen Assistant and Waste Disposal
Issued by Elijah's Promise on Mar 2015
Associated with Vivek P.Reading Coach
Issued by Highland Park Public Library on Jun 2014
Associated with Vivek P.
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