Lissette Serrano, PE, ASQ CQE
Senior Program Manager at Synchron- Claim this Profile
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Spanish Native or bilingual proficiency
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English Native or bilingual proficiency
Topline Score
Bio
Credentials
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ISO 13485:2016 Lead Auditor
BSIAug, 2022- Nov, 2024 -
Professional Engineering (PE)
Puerto Rico Examining Board of Engineers and Land SurveyorsApr, 2013- Nov, 2024 -
Certified Quality Engineer (CQE)
ASQ
Experience
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Synchron
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Senior Program Manager
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May 2022 - Present
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Medtronic
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Engineering Program Manager
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Nov 2019 - May 2022
Program Manager in the Operations PDP Implantables team
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Principal Manufacturing Engineer
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Dec 2018 - Nov 2019
Responsible for the evaluation, analysis, and implementation of projects driving cost reduction of manufacturing processes that provide implantable components to finished devices.
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New Product Introduction Project Manager
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Jul 2017 - Dec 2018
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Sr Manufacturing Engineer
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May 2016 - Jul 2017
New Products and Technology Innovation
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Sr Supplier Quality Engineer
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Aug 2014 - Apr 2016
Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation.
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Supplier Quality Engineer
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Sep 2013 - Aug 2014
Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation.
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Amgen
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United States
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Biotechnology Research
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700 & Above Employee
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Process Engineer
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Mar 2010 - Aug 2013
Experience in Process Development, Process Engineering, and Commercial Manufacturing support. Support mainly focused in existing commercial processes for a multi-product bulk processing facility. Experience includes support for Fermentation/Cell Culture and Purification processes. Experience with process performance monitoring and translation of engineering principles to the manufacturing environment. Familiarized with the execution and revision process of manufacturing procedures and with the documentation pertinent to a cGMP environment. Have led the gathering, monitoring and analysis of data to support technology transfer activities, commercial production, optimization projects and nonconformance investigations. Collaboration with personnel from different areas such as: Quality, Manufacturing, Automation, Supply Chain, Dispensing, Warehouse and Process Development laboratories.
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Eli Lilly and Company
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Process Engineer - COOP Student
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Jan 2008 - Dec 2008
Worked as a Process Engineer for the Fermentation department of a biopharmaceutical plant dedicated to the manufacture of the API of Humalog. Focused on the operation and maintenance of the manufacturing process, as well as troubleshooting. This included performing Periodic Quality Evaluations to assess the validation state of the systems, P&ID walkdowns and SOP revisions. Monitored modifications and upgrades, and troubleshooted existing processes; prepared reports, flow diagrams and charts; made observations as well as collected and interpreted data to improve process cycle time. Obtained a general understanding of the workflow for generating and implementing a change control.
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Education
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University of Puerto Rico-Mayaguez
Bachelor of Science (BS), Chemical Engineering