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Process Engineer Resume Example

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PROCESS ENGINEER
Professional Summary
Results-oriented Process Engineer known as a consistent team player with skilled technical abilities and detail-oriented with strong Pharmaceutical Science education background supported by research and professional work experience in manufacturing and engineering areas.
Areas of Expertise
  • Lean manufacturing
  • Performance optimization
  • Creative problem solving
  • Aseptic techniques
  • Multi-project coordination
  • Guidelines: EU, ICH, US FDA, GAMP5, PDA
  • cGMP, GDP, ISO standards, ISPE
  • Process Monitoring and Data Analysis
  • Root Cause Analysis
  • Process Assessment and Validation
Research and Work Experience
Process Engineer 03/2016 to Current
Pharmalucence, Inc. (A Sun Pharmaceutical Company) – Billerica, MA
  • Served as a point of contact for technology and product transfers, engineering studies, and other transfer deliverables.
  • Worked on highly complex problems where instant evaluation and analysis of imperceptible glitch was required to continue ongoing project.
  • Established calibration and preventive standards, training materials, standard operating procedures relating to existing and new technologies.
  • Designed and executed process capability studies to mitigate routine technical issues encountered during manufacturing activities on the isolated filling system.
  • Responsible for creating and delivering training materials to users of Filling Technology, Sterilizers, Depyrogenation Oven, and Lyophilizers.
  • Reviewed equipment\'s P&ID, User Requirement Specification (URS), Functional Specification (FS), Design Specification (DS), Alarm matrix, and other documents as part of technical gap analysis exercise between equipment manufacturer\'s site and Pharmalucence.
  • Performed Factory Acceptance Test (FAT) of new isolator technology to demonstrate system meets approved specifications and operates as per the requirements of Pharmalucence.
  • Supported validation engineering group to prepare validation protocols in support of qualification activities of newly purchased isolator technology.
  • Responsible for working with the Original Equipment Manufacturers (OEM) to acquire knowledge on new products, resolve complex issues and develop preventive measures.
  • Provided subject matter expertise in support of process and equipment related critical events such as investigation, deviations, change controls, CAPA, DCRs.
  • Ensured equipment's are maintained in a cGMP compliant state at all the times.
Formulation and Fill Chemist 10/2013 to 02/2016
Pharmalucence, Inc. (A Sun Pharmaceutical Company) – Billerica, MA
  • Developed detailed procedures (Batch Record, Summary Reports, SOPs, training documents, performance assessment checklist.) for the new processes and equipment's.
  • Assumed lead role in communicating and coordinating operation activities in absence of area supervisor, and trained operators on the new processes associated with advanced isolated filling technology.
  • Collaborated with R&D group to design and develop washer, sterilizer, depyrogenation oven process configuration and other formulation processes for the CBE-30 and new products to be manufactured.
  • Supported engineering groups to establish formal experimental plan to assess performance of new parts and components on the filling technology.
  • Identified and developed material specifications document for new raw materials and long-standing ones.
  • Completed final formulation of the drug product via aseptic technique.
  • Reviewed completed batch records, logbooks and SOPs in accordance with cGMP and GDP standards.
  • Interacted and supported other functional groups Validation, Quality Control, Quality Assurance, and Engineering
Manufacturing Associate 11/2011 to 09/2013
Lonza Biologics, Inc – Hopkinton, MA
  • Purified recombinant proteins from end of fermentation activities to bulk fill of product using small and large scale chromatography systems (GE AKTA, Varian), tangential flow filtration (TFF) including Ultrafiltration/Diafiltration and normal flow filtration.
  • Packed columns ranging from 30cm to 80cm in diameter such as GE BPG, GE Chromaflow, and Eastern Rivers (ERVB) columns, and calibrated laboratory equipment.
  • Performed chromatography and qualification testing (HETP and Asymmetry) using Unicorn software and manual calculations on packed column resin bed.
  • Reviewed, edited, and revised completed batch records, logbooks, and SOPs in accordance with cGMP standards.
  • Performed and documented all activities in compliance to Good Manufacturing Practice (GMP) using following systems: Document Management System (DMS), Laboratory Information Management System (LIMS), and SAP. Initiated deviations using Trackwise System.
  • Applied six sigma/lean manufacturing principles to optimize efficiency within the manufacturing laboratory.
Undergraduate Researcher 09/2010 to 12/2010
Massachusetts College of Pharmacy and Health Sciences – Boston, MA
  • Compared the in-vitro drug release pattern for both brands of Lansoprazole (one Rx and one OTC), and predicted the specific site of drug release in the gastrointestinal tract via convolution.
  • Spectroscopic analysis via UV/Vis Spectrophotometer of Lansoprazole was followed by HPLC analysis using X-Terra Column (Waters).
  • Plasma concentration time curve of the IV bolus was created to help with convolution.
Education
Bachelor of Science: Pharmaceutical Science May 2011 Massachusetts College of Pharmacy and Health Sciences - Boston, MA
Acknowledgements
  • Pharmalucence Inc., Certificate of Appreciation November 2014.
  • Lonza Biologics, Inc. Award for Excellence July 2013.
Poster Presentation
Chuong M, Crosby S, Patel P, Alsulimani H, Tan J, Valladares M, Ubhe A, Vo L. "In-Vitro Release   of Lansoprazole Delayed-Release Capsules and Convolution Study". Poster Session Presented at: 14th Annual Meeting of American Association of Pharmaceutical Scientists- North East Regional Discussion Group; 2011 April; Rocky Hill, CT.
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Resume Overview

Companies Worked For:

  • Pharmalucence, Inc. (A Sun Pharmaceutical Company)
  • Lonza Biologics, Inc
  • Massachusetts College of Pharmacy and Health Sciences

School Attended

  • Massachusetts College of Pharmacy and Health Sciences

Job Titles Held:

  • Process Engineer
  • Formulation and Fill Chemist
  • Manufacturing Associate
  • Undergraduate Researcher

Degrees

  • Bachelor of Science : Pharmaceutical Science May 2011

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