Forward-thinking Process Engineer with experience in process design and establishing manufacturing routines. Looking to bring further success to an organization through astute skills in change improvements, process tools, and problem analysis.
Areas of Expertise
Process Engineering
Project Management
Teamwork / Collaboration
Six Sigma
Creative problem solving
Process Monitoring and Data Analysis
Lean Manufacturing
Performance optimization
Research and Work Experience
09/2016 to Current
Process EngineerEvraz, Inc. – Chicago, IL,
Reviewed technical documents such as equipment GA drawing, P&ID, User Requirement Specification (URS), control philosophy, alarm matrix, FAT, SAT, IOQ for Soloflex flexible Isolator, Vessels
Designed and executed process capability studies to mitigate routine technical issues encountered during manufacturing activities
Successfully completed feasibility and process characterization batches (Exhibit Batches) of injectable (Vial Line and Pre-Filled Syringes) and respiratory (Blow Fill Seal) products
Proactively identified ways to simplify the manufacturing process by reducing variables (i.e. solution transfer loss) and minimizing human interventions
Successfully completed feasibility and process characterization batches of injectable (Vial Line and Pre-Filled Syringes) and respiratory (Blow Fill Seal) products
Co-ordinated with R&D and cross-functional team to understand plant requirements and tooling as per the product requirement
Provided subject matter expertise in support of process and equipment related critical events such as investigation, deviations, change controls, CAPA, DCRs
Assisted Finance team prepare short term and long term capacity utilization in preparation for commercialization
02/2016 to 09/2016
Process EngineerEvraz, Inc. – Colorado Springs, CO,
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
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
09/2013 to 01/2016
Formulation And Fill ChemistAbcam Plc – Milpitas, CA,
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
Supported engineering groups to establish a formal experimental plan to assess performance of new parts and components on the filling technology
Completed final formulation of the drug product via aseptic technique
Interacted and supported other functional groups Validation, Quality Control, Quality Assurance, and Engineering
10/2011 to 08/2013
Manufacturing AssociateLonza Biologics, Inc – City, STATE,
Purified recombinant proteins from end offermentation activities to bulk fill of product using small and large scalechromatography systems (GE AKTA, Varian), tangential flow filtration (TFF)including Ultrafiltration/Diafiltration and normal flow filtration
Packedcolumns ranging from 30cm to 80cm in diameter such as GE BPG, GE Chromaflow,and Eastern Rivers (ERVB) columns, and calibrated laboratory equipment
Performedchromatography and qualification testing (HETP and Asymmetry) using Unicorn softwareand manual calculations on packed column resin bed
Reviewed, edited, and revised completed batchrecords, logbooks, and SOPs in accordance with cGMP standards
Performedand documented all activities in compliance to Good Manufacturing Practice(GMP) using following systems: Document Management System (DMS), Laboratory InformationManagement System (LIMS), and SAP. Initiated deviations using Trackwise System
Applied six sigma/lean manufacturingprinciples to optimize efficiency within the manufacturing laboratory.
Education
Expected in 2011
Bachelor of Science: Pharmaceutical Science Massachusetts College of Pharmacy and Health Sciences - Boston, MA, GPA:
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School Attended
Massachusetts College of Pharmacy and Health Sciences
