Process Engineer Resume Example Pharmalucence, Inc. (A Sun Pharmaceutical Company)

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 Engineer03/2016 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 Chemist10/2013 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 Associate11/2011 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 Researcher09/2010 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 ScienceMay 2011Massachusetts 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.

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

Process Engineer Resume Example

Resume Score: 90%

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