Manufacturing Engineering
Resume:
Veronica Moreno
************@*****.***
SUMMARY
A resourceful Engineering tech III with excellent communication skills that is self-motivated and enthusiastic in achieving goals. A dependable, thorough and responsible team player that works well under pressure and handle multiple tasks simultaneously. Willing to take new challenge.
PROFESSIONAL EXPERIENCE
Kedalion Therapeutics Menlo Park Cal, May 2017 – Sep 2017
R&D Tech
Run calibration procedures/ processes.
Operate and maintain manufacturing equipment and maintain production readiness.
Execute first particle
Self-managed assigned tasks to permit schedule flexibility and the processing of expedited testing and manufacturing assignments
Maintained accurate and well-organized records, worksheets and/or notebook
Highly proficient in the use of manufacturing equipment such as: oscilloscope equipment, Microscope inspection, soldering, and customized flow rate measurement.
Pearl Therapeutics Redwood city, CA Dec 2014 – March 2017
Process Tech III
Successfully executed complex design validation testing for all critical new products before and after product launch.
Operate and maintain manufacturing equipment and maintain production readiness.
Execute particle manufacturing operations in cGMP facility at Pearl, including: Operate, Clean, and Maintain production equipment.
Sample product and raw materials for release testing.
Dispense raw materials for manufacture.
Conduct preventative maintenance activities, where appropriate. Assist in maintaining equipment records pertaining to PM and calibration activities, and equipment warranties.
Communicate production successes and issues to PDM engineers and management to improve manufacturing operations.
Document production activities per SOPs and cGMPs.
Maintain the inventory of consumables and supplies required for production.
Support Materials Management operations: Receive materials used in cGMP production per SOP. Package and ship cGMP materials per SOP or protocol. Assist in maintaining warehouse operation per SOP.
Maintain a safe working environment Observe and follow all safe operation practices. Maintain a clean and clutter-free production environment.
Review and revise documentation to ensure documents adhere to company quality requirements and documentation is compliant with specified regulations. This includes Batch production records and logbooks.
Operate feedstock preparation equipment
Operate spray dryer and perform collector change outs
Operate jet milling equipment and perform collector change outs
Clean and maintain spray drying, feedstock preparation, and jet milling Novartis San Carlos, CA Jan 2009- Jun 2014
Engineering Tech III
Successfully executed complex design validation testing for all critical new products before and after product launch.
Recognized for being a key member of the Vapor Device Assembly project: collected data for FDA submission and commercial release.
Worked very closely with engineering on all new designs providing constant feedback for continuous improvement in DFM (design for manufacturability) and reach higher quality levels.
Responsible for data collection, analysis and next steps.
Effectively multi-tasked projects to support engineering and manufacturing activities
Evaluated design improvements to currently released products to assess performance changes
Self-managed assigned tasks to permit schedule flexibility and the processing of expedited testing and manufacturing assignments
Manage a production line to assemble medical devices following strict FDA & GMP guidelines.
Coach and mentor junior technicians in multiple procedures to ensure both production and compliance goals are met.
Effectively trained (certified trainer) new hires on all product lines emphasizing on workmanship and process quality.
Lead technician for research and development and interact with device engineering to perform manufacturing functions and expertise on other device development projects. Work closely with engineers to provide instant feedback to experiments and assure process optimization.
Opening and closing PI Sheet on SAP.
Review and revise documentation to ensure documents adhere to company quality requirements and documentation is compliant with specified regulations. This includes Batch production records and logbooks.
NEKTAR THERAPEUTICS San Carlos, CA Nov 2007-Dec 2008
Engineering Tech III
Executed design validation testing Vapor device Assembly project; collect data for FDA submission and commercial release. And Working on new design working closely with Eng.
Assume responsibility for data collection and analysis
Support engineering and manufacturing activities as required.
Evaluated design improvements to currently released products to assess performance changes
Self-managed assigned tasks to permit schedule flexibility and the processing of expedited testing and manufacturing assignments
Performed complaint investigation appropriately escalating issues to management
Maintained accurate and well-organized records, worksheets and/or notebooks.
Lead failure investigation.
Organize the return of clinical trials materials from variety of source.
Performed complaint and planned return trend analysis.
Support engineering and manufacturing activities as required.
Conducted PDS andT-326 field returns investigations such that design failure modes are identified and Good Documentation Practices are maintained; processes of field returns investigations ahead of projected schedule and restored compliance to internal thirty-day investigation closure policy.
Highly proficient in the use of manufacturing equipment such as: Rofin Sinar laser marking equipment, Microscope inspection, Spraytech VMD (Volume Median Diameter) metrology, soldering, and customized flow rate measurement.
NEKTAR THERAPEUTICS San Carlos, CA Feb 2006-Oct 2006
Product Complaint Assistant III
Conducted Aeroneb® Go Nebulizer and Core field returns investigations such that design failure modes are identified and Good Documentation Practices are maintained; processed a three month backlog of field returns investigations ahead of projected schedule and restored compliance to internal thirty-day investigation closure policy.
Executed design validation testing on Aeroneb® Go 1.2 AG Core Assembly project; collect data for FDA submission and commercial release.
AEROGEN, INC. Mountain View, CA 2001-2006
R&D Technician (01/2005 –01/2006)
Performed qualification of new manufacturing processes and equipment in order to verify production yield improvement while maintaining product compliance to performance specs.
Conducted Aeroneb® Go Nebulizer and Core field returns investigations such that design failure modes are identified and Good Documentation Practices are maintained; processed a three month backlog of field returns investigations ahead of projected schedule and restored compliance to internal thirty-day investigation closure policy.
Evaluated design improvements to currently released products to assess performance changes
Executed design validation testing on Aeroneb® Go 1.2 AG Core Assembly project; collect data for FDA submission and commercial release.
Inspected raw materials for compliance to component specifications, in order to ensure use of quality-compliant materials in the manufacturing process.
Performed wafer optical density metrology and aperture plate processing in order to maintain and improve target-manufacturing efficiency.
Manufacturing Technician (04/2004 – 01/2005)
Balanced the manufacturing line process flow in order to reduce the incidence of bottlenecking and improve throughput efficiency.
Assisted in the qualification of the manufacturing floor inventory-tracking database (PCS), achieving scheduled implementation date.
Conducted qualification of product performance assessment technology (SGK-300 Flow Rate Test Stations), achieving implementation on schedule.
Trained manufacturing floor personnel in build procedures in order to maintain Good Manufacturing Procedures (GMP) compliance.
Contributed to the development and documentation of manufacturing procedures and test protocols, to ensure accurate descriptions of implemented processes.
Assembler (02/2001 – 04/2004)
Analyzed manufacturing procedures to resolve line issues and improve processing efficiency.
Audited production documentation and Device History Records against yielded inventory for compliance to manufacturing procedures and to eliminate loss of yielded product.
Performed release testing of commercially available Aeroneb® Portable Nebulizer System to ensure product compliance to performance specifications.
Assembled plastic, metal, and ceramic components into medical devices in accordance with approved manufacturing procedures to meet and exceed target production quotas.
Conducted in-process quality checks on sub-assemblies and finished product to maintain compliance with product specifications.
Maintain accurate records and documentation related to quality, work in progress, test results, and special projects.
Education
Cabrillo College, Aptos, CA (2 years General Education)
Additional Skills
Microsoft Office: Word, Excel, and Outlook.File Maker, Data Base Entry, BPR reviewer, Clean room certified, ISO/FDA knowledge, SAP knowledge, Packaging of medical devices . Experience using basic measuring equipment (e.g.,Soldering, calipers, micrometers, microscopes, optical measuring tool etc.).
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