Livecareer-Resume
Jessica Claire
Montgomery Street, San Francisco, CA 94105
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Professional Summary

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 Engineer Evraz, 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
  • Reviewed TTD documents (QTPP, PFMEA, MFC, MPC, RLD, FP/API/RM specification sheet, stress analysis data, and BOM), BPRs, filter validation protocols, and reports
  • 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 Engineer Evraz, 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 Chemist Abcam 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 Associate Lonza 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:

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

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:

92Good

resume Strength

  • Length

Resume Overview

School Attended

  • Massachusetts College of Pharmacy and Health Sciences

Job Titles Held:

  • Process Engineer
  • Process Engineer
  • Formulation And Fill Chemist
  • Manufacturing Associate

Degrees

  • Bachelor of Science

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

*As seen in: