Molly Leasure

Senior Validation Engineer at Lifecore Biomedical
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Minneapolis-St. Paul Area

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Experience

    • United States
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Senior Validation Engineer
      • Jun 2022 - Present

      Supervise, lead and develop the validation team- responsible for all equipment implementation, risk assessment, validation and change management.Create an onboarding process for newly hired validation employees, including training plans and performance assessment material. Review process data and current industry trends to proactively identify potential problems and implement activities to maintain compliance to associated standards.

    • Lead Validation Engineer
      • Jun 2021 - Jun 2022

    • Validation Engineer
      • Jun 2020 - Jun 2021

      Responsible for validation of all steady state and developmental equipment and software, including protocol writing, execution and report creationAssist in the execution of multiple internal auditsRedesigned internal QMS for the implementation of new equipmentAssess risks associated with the addition of new equipment of changes to current equipment utilizing FMEAsAid in the completion of FAT, SAT and development testing in coordination with the engineering team.Support Risk Management activities for product and other department complaints. Show less

    • Associate Design Quality Assurance Engineer
      • Jun 2019 - Jun 2020

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Validation Engineer, Vangard Labs
      • Jun 2017 - May 2019

      - Performed all equipment qualification activities, totaling $10M of thermoforming, digital printing, and lab equipment -Authored and executed IQ/OQ/PQ protocols for all equipment to ensure compliance with cGMP requirements -Created, revised and updated SOPs related to new equipment purchases and process improvement -Project lead for stability chamber summing to $50k, including contracts, purchasing, documentation and installation. - Performed all equipment qualification activities, totaling $10M of thermoforming, digital printing, and lab equipment -Authored and executed IQ/OQ/PQ protocols for all equipment to ensure compliance with cGMP requirements -Created, revised and updated SOPs related to new equipment purchases and process improvement -Project lead for stability chamber summing to $50k, including contracts, purchasing, documentation and installation.

    • Higher Education
    • 700 & Above Employee
    • Competitive Sports Office Assistant
      • Aug 2016 - May 2017

      Manage operations of competitive sports office using knowledge of Microsoft Office, Google Drive, and FusionAccurately complete and organize paperworkAssist with scheduling employees and gamesUpdating multiple social media sites

    • EFX Mentor
      • Aug 2016 - May 2017

      Attend weekly meeting of first year ABE student's classTeach lessons on the program Inventor during class meetingsHold office hours for tutoring and mentoring

    • Intramural Sports Supervisor
      • Aug 2014 - May 2017

      Hire, train, supervise, and evaluate officials and scorekeepers of intramural sportsPrepare playing area and have knowledge of rules for 25 different sportsMonitor and maintain safe environment through conflict resolution and first aid trainingHiring Committee 2015, 2016Intramural Supervisor of the Year 2014-2015Recreational Sports Student Advisory Board 2015-2016

    • Undergraduate Research Assistant
      • Jan 2016 - Apr 2016

      Assisted in extensive literature reviews to assemble information for a proposal presentationUsed 2D and 3D CAD software to compile drawings of hip implantPresented research at 2016 Undergraduate Research Symposium

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Otolaryngology Research Intern
      • Jun 2016 - Aug 2016

      Created documentation and drawings for FDA application of Percutaneous Cochlear Implant devices Inspected machined parts using FARO software Documented process development and standard operating procedure Developed and completed experimental procedures; including the machining of parts on CNC machine Created documentation and drawings for FDA application of Percutaneous Cochlear Implant devices Inspected machined parts using FARO software Documented process development and standard operating procedure Developed and completed experimental procedures; including the machining of parts on CNC machine

    • United States
    • Restaurants
    • 700 & Above Employee
    • Sandwich Maker/ Delivery Driver
      • Apr 2011 - Aug 2015

      Answered phones and took orders on computerized system Interacted with guests in a fast-paced environment Delivered orders with safety, speed, and accuracy Completed inventory Answered phones and took orders on computerized system Interacted with guests in a fast-paced environment Delivered orders with safety, speed, and accuracy Completed inventory

  • Williamson County Parks and Recreation
    • Greater Nashville Area, TN
    • Camp Counselor
      • May 2014 - Aug 2014

      Planned and executed daily activities for over 100 children Entertained children with a variety games and crafts Directed fields trips for over 200 people Planned and executed daily activities for over 100 children Entertained children with a variety games and crafts Directed fields trips for over 200 people

    • Volunteer/Shadow
      • May 2014 - Jul 2014

      Completed paperwork for volunteer projects Organized files for patients Shadowed employees in multiple areas Completed paperwork for volunteer projects Organized files for patients Shadowed employees in multiple areas

Education

  • Northeastern University
    Graduate Certificate, Quality Assurance in Biomedical Product Regulation
    2021 - 2023
  • Mississippi State University
    Bachelor's degree: Biological Engineering, Biomedical/Medical Engineering
    2013 - 2017
  • Centennial High School
    High School
    2009 - 2013

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