Sophie Hu
Process Engineer @Trinity Consultants - Advent Engineering
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WORK HISTORY
Process Engineer @Trinity Consultants - Advent Engineering
Norton, MA, US
Ownership and management of equipment related site change control projects >$500k•Design, submittal review, and FAT to support procurement, fabrication/installation of new GMP equipment and systems such as HPLC columns and packing skids, COP stations, and TCUs•Development of functional, configuration, and equipment specifications to support equipment upgrade and procurement projects. •Ongoing engineering support for equipment and processes for a GMP manufacturing facility to improve efficiencies and address issues in order to minimize impact on production schedules •Start-up of aqueous and solvent CIP and COP. Cleaning recipe development for solvent-based cleaning system •Start-up of solvent delivery and organic waste systems •Development of a site-wide alarm rationalization document. Development of a site-wide procedure for development and execution of engineering test plans.•Generation and execution of Factory Acceptance Testing for all new process equipment purchased for a green field oligonucleotide manufacturing facility
EDUCATION
University of Toronto
Bachelor of Applied Science and Engineering with Honours, Chemical Engineering
ABOUT SOPHIE HU
Engineering and CQV experience in the pharmaceutical manufacturing industry. Experience with capital projects, green-field projects, as well as day-to-day manufacturing support.
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