Experience

Kymanox

• United States
• Biotechnology
• 100 - 200 Employee

• Process Engineer

  • Jan 2023 - Present

  - Served as technical lead on tracking and developing equipment System Risk Assessments for client’s QMS development.- Led the assessment and remediation of analytical lab equipment for 21 CFR Part 11 compliance.- Provided defense and support to client SME’s for their first on-site regulatory audit.- Assisted with remediating gaps in on-site cleaning validation, and cleaning monitoring programs.- Supported the entire qualification process including protocol authoring, reviewing, on-site execution, summary report drafting and routing for approval for time-sensitive audit deadlines.- Provided process engineering support for the transition from clinical stage product to commercial stage.- Supported a variety of validation projects including: cleaning validation, computer systems validation for 21 CFR Part 11 compliance, equipment validation for qualifying temperature control units (TCU's - refrigerators, freezers, and incubators), chromatography skids, and other lab and process equipment. Show less

• Associate Validation Engineer

  • Jun 2021 - Jan 2023

  - Support a variety of validation projects including: cleaning validation, computer systems validation for 21 CFR Part 11 compliance, equipment validation for qualifying temperature control units (TCU's - refrigerators, freezers, and incubators), chromatography skids, and other lab and process equipment.- Provide hands-on technical support for clients to ensure on time project success and to meet critical audit response deadlines.- Write, review, and execute validation protocols for the qualification of equipment and processes.- Work in a cross functional team between development and commercial facilities to assist with the transfer of manufacturing/process knowledge and prevent critical downtime on the commercial level.- Lead troubleshooting and root cause analysis for atypical manufacturing events. Show less



bluebird bio

• United States
• Biotechnology Research
• 300 - 400 Employee

• MSAT Intern

  • Jan 2021 - Mar 2021

  - Supported Process Tech Transfer with data verification, collection, and authoring of reports- Utilized Excel to support report development and verification- Contacted vendors for equipment and material information

• Vector Manufacturing Intern

  • May 2020 - Dec 2020

  - Provided technical support for the manufacture of a gene therapy product. Troubleshooted process or equipment related issues and developed sound engineering solutions to address identified problems.- Coordinated activities to support manufacturing (i.e. raw materials, cGMP cleaning and gowning, and BPR issuance) as needed.- Wrote and revised standard operating procedures (SOPs) to maintain a GMP operation.- Provided on the floor support during manufacturing operations.



North Carolina State University

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate Research Assistant

  • Aug 2019 - Dec 2019

  - Evaluated micelle polymer and nanoemulsion formulations to create a physical hydrogel intended for drug delivery. - Trained with advanced machinery for testing Rheometry, and Dynamic Light Scattering - Designed and planned experiments to test the effectiveness of methods to generate hydrogel products - Organized and recorded a lab notebook to keep track of experimental data - Evaluated micelle polymer and nanoemulsion formulations to create a physical hydrogel intended for drug delivery. - Trained with advanced machinery for testing Rheometry, and Dynamic Light Scattering - Designed and planned experiments to test the effectiveness of methods to generate hydrogel products - Organized and recorded a lab notebook to keep track of experimental data



North Carolina State University

• United States
• Higher Education
• 700 & Above Employee

• Community Assistant Coordinator

  • Aug 2018 - May 2019

  - Supervise the operations of a team of 30 Community Assistants to ensure that our help desks run efficiently and remain organized. - Train incoming employees on responsibilities that are expected of them and policies that they need to follow. - Cooperate and communicate with all members of the residence halls and University staff so that quality customer service is provided. - Prepare and distribute staff schedules, important announcements, and run monthly staff meetings - Work several in-office shifts of general help desk duties including logging packages, equipment rentals and answering questions. Show less



The Fresh Market

• United States
• Retail
• 700 & Above Employee

• Produce Clerk

  • May 2018 - Aug 2018

  - Unloaded shipments and stocked a variety of the department’s fruits, vegetables and specialty items. - Physically made and packaged fresh produce by following recipes and processes indicated in training manuals. - Assisted customers in locating items and personally making special products per customer request. - Worked independently to organize and maintain the overall appearance of the department. - Unloaded shipments and stocked a variety of the department’s fruits, vegetables and specialty items. - Physically made and packaged fresh produce by following recipes and processes indicated in training manuals. - Assisted customers in locating items and personally making special products per customer request. - Worked independently to organize and maintain the overall appearance of the department.