Engineer Quality

KELVIN LI

****S. Halsted St, Chicago, IL ***** 312-***-**** ************@*****.*** LinkedIn Profile

CHEMICAL PROCESS ENGINEER, QUALITY ENGINEER

CAREER SUMMARY

Have one year of working experience of process engineer in pharmaceutical industry.

BS in Pharmaceutical Engineering; MS in Chemical Engineering.

Possesses knowledge of Continuous Improvement, Reliability and quality development skills (ISO9001, ISO13485, SOP, GMP, GDP, Lean Manufacturing, Statistical Process Control, HSE/PSM, PHA, HACCP, HAZOP, CAPA, QMS, GLP, PLC) with strong ability to interpret blue prints (PFD, P&ID’s), safety rules & standards, and use tools in SPC, Kaizen, SMED, DOE, FMEA, Control Plans, 8D, AutoCAD, Aspen Plus.

Develop negotiation & ERP skills (SAP), Six Sigma (Minitab) DMAIC, Value stream mapping, Root Cause Analysis, MS Office. Leadership, Teamwork, Good communication skills, self-starter, Project Management.

EXPERIENCE

Process Engineer May 2014 - May 2015

Lishizhen Pharmaceutical Group Co, Ltd, Huanggang, China

Supported Capital Green project as team member by implementing RCA/FMEA, Process Safety Minimum Expectations (PSME), and PHA, assisting in PSM Auditing for the Unit, integrating control technology, and using lean manufacturing principles and Six sigma on OSHA's Process Safety Management, ISO13485 requirements, cGMP regulations and ERP system, achieving $10000 savings while meeting 1-year project timeline.

Drove continuous improvement in safety, quality, delivery, and cost through analysis of plant data and collaboration with Operations and Maintenance personnel, following Project Management, Incident investigations and process instrumentation, and overseeing installation on SOP regulations and ISO9001 requirements, meeting $15000 budget goals and 6-month project timeline.

Designed and optimized distillation column in Aspen Plus by assisting in Unit root cause failure analyses (RCFA), resolving product, process and customer issue during all phases of the product life cycle using tools such as 8D, kaizen, and Statistical Process Control to ensure effective corrective and preventive action on Quality/Process investigations, reducing process cycle time by 5% and achieving $5000 savings.

Assisted with analyses on process optimizations to scale up processes by reviewing PFD, P&ID’s in AutoCAD, supporting technology selection and equipment testing, applying Lean production methods (Value stream mapping, DOE, Six Sigma, SMED) to project reduction on PLC system, improving process efficiency by 8%.

Quality Engineer Sep 2013 - Apr 2014

Xiangyang Longzhong Pharmaceutical Group Co, Ltd, Xiangyang, China

Assisted with Capital Project as quality engineer by creating Validation & Qualification plans, protocols and results, selecting appropriate sampling plans and testing requirements for equipment Installation Qualification (IQ)/Operational Qualifications (OQ) tests on ISO 13485 requirements and GMP regulations, meeting $5000 budget goal and 6-month project timeline.

Supported Process Reviews to streamline processes and increase Quality throughput by utilizing common quality practices (CMMS, design assurance, Total Quality Management, Process Control) and sustaining QSR/ISO regulations, meeting $4000 savings and 6-month project timeline.

ACADEMIC PROJECTS

Photovoltaic (PV) Renewable Energy Generation Aug 2015 - Dec 2015

Conducted feasibility and study of project business strategy. Analyzed technology improvements to improve efficiency in solar energy industry.

Synthesis of 4-Amino-2-(trifluoromethyl) benzonitrile as the intermediate of Bicalutamide Feb 2015 - Jun 2015

Chemical analytical testing, UV, GC, HPLC, TLC, crystallization, distillation, extraction, chromatography.

EDUCATION

MS in Chemical Engineering Illinois Institute of Technology, Chicago, United States Aug 2015 - May 2017 Mass & Energy balances, Hydraulics, Heat Transfer, Food Process Engineering, Transport Phenomena, Thermodynamics, Chemical reaction engineering, Renewable Energy Technologies, Process control.

BS in Pharmaceutical Engineering Wuhan Institute of Technology, Wuhan. China Aug 2011 - June 2015

Chemical process modeling, Process and plant design, Separation Processes, Physical Chemistry, Organic chemistry, Fluid Mechanics, Separation Processes, Analytical chemistry, membrane separation.

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