Process Engineer Resume Example
Love this resume?Build Your Own Now
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
|
|
Research and Work Experience
Process Engineer03/2016
to Current
Evraz, Inc. – Chicago , IL
Evraz, Inc. – Chicago , IL
- 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
Evraz, Inc. – Colorado Springs , CO
Evraz, Inc. – Colorado Springs , CO
- 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
Abcam Plc – Milpitas , CA
Abcam Plc – Milpitas , CA
- 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
Lonza Biologics, Inc – City , STATE
Lonza Biologics, Inc – City , STATE
- 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-
City,
State
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.
DISCLAIMER
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
How this resume score could be improved?
Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:
Resume Strength
- Completeness
- Formatting
- Word choice
- Measurable results
- Clear contact info
- Typos
Resume Overview
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
Similar Resumes
