Sonal Mistry

Chemical Engineering graduate with bioprocessing and lab operations experience, including process development support, equipment commissioning, controlled documentation, and GLP/cGMP compliance. Experienced supporting manufacturing, validation, and R&D lab processes in regulated environments. Has experience working in regulated labs in a leadership position.

CAD Drafter - Pike Telecom - Mansfield MA

(2024-10)

• Drafted detailed engineering design drawings using CAD software in a fast paced environment. Drawings include structure, schematic, foundation, grounding, layout, wiring, panels in accordance with clients requests.
• Filed drawings, maintained catalogs of engineering data and compiled engineering packages.

Process Engineer I - Massbiologics - University of Massachusetts Chan Medical School - Mattapan MA

(2022-02 - 2024-02)

• Supported manufacturing process engineering projects by developing equipment specifications, assisting with equipment selection, and supporting installation and commissioning of process equipment for manufacturing and process development.
• Created controlled technical documentation, including SOPs, change controls, deviation reports, and work orders, to support equipment installation, process changes, and compliant manufacturing operations.
• Supported and backed risk assessments and deviation investigations to identify equipment/process risks, improve preventative maintenance understanding, and help define actions to minimize system failures.
• Supported upstream and downstream process development activities through manufacturing transfer, including process scale-up from 50L to 250L batches.
• Supported IT as an Subject Matter Expert for CFR part 11 compliance documentation to ensure it follows current Good Manufacturing Practice requirements.
• Wrote and performed IOPQ and engineering test procedures for manufacturing equipment including bioreactors, filter integrity testers and chromatography systems.

Lab Technician - Labcorp - Westborough MA

(2020-08 - 2022-02)

• Performed automatic DNA extraction using Tecans, Chemagens for blood samples and manual DNA extraction for blood and prenatal samples. Achieved quants for the extracted DNA samples using a Spectramax machine.
• Trained others in DNA and RNA extraction, took up a leadership position in a team environment and made sure everything that needed to be performed was efficiently completed.
• Experienced with 5S, using Personal Protective Equipment, Good Laboratory Practices and Preventative Maintenance.

Lab Technician Co-op - Creative Materials - Ayer, MA

(2017-12 - 2018-08)

• Experienced using viscometers, finding conductivity, three roll milling, TCR testing, mandrel and hegman testing, shearing and degassing equipment. Hands-on experience working with solvents and fillers to make conductive and non-conductive adhesive materials.

Bachelor of Science - Chemical Engineering - University of Massachusetts Lowell (2020-05)