ERNIE SWANSON

*** ********** ***, *********, ** *4087

408-***-**** or 408-***-****

vhryef@r.postjobfree.com

http://www.linkedin.com/in/ernieswanson

Experienced in leading project teams to purchase, install, start up and modify the equipment and systems used in pharmaceutical manufacturing and semiconductor wafer fabrication.

Lead Process Engineer that successfully installed a new technology to measure vials for raised stoppers. The project was on time, under budget and met its objectives. The total project budget was $1.5 million.

Lead Process Engineer for the start up of a clinical aseptic vial filling facility. This included the purchase, installation, startup and validation of vial washers, fillers, lyophilizers, depyrogenation tunnel and oven, cappers and autoclaves.

Used statistical process control, six sigma methodology, Pareto analysis, FMEA, formal and informal teams to solve day to day and ongoing manufacturing and equipment problems.

Wrote operations and maintenance procedures to improve the overall equipment utilization and reduce cycle times.

Trained technicians to run, setup and repair the equipment.

SKILLS:

6 Sigma Green Belt

Solid Works

Systems Integration

Technical Writing (SOPs and PM SOPs)

Cost Reduction

Team Leadership

Problem Solving

Cross Functional Teams

Reduced Cycle Time

Factory Layout

Continuous Improvement

Failure Mode Effects Analysis (FMEA)

Statistical Process Control (SPC)

Training

Meeting Facilitation

cGMP

WORK EXPERIENCE:

R & D Engineer, Abbott Vascular, Santa Clara, CA

November 2011 to Present (Contract position)

Responsible for improving the testing and manufacturing processes used to manufacture drug-eluding bioresorbable stents.

Improved the manufacturing processes used to build drug-eluding stents.

Wrote and executed protocols to test catheters and drug-eluding stents.

Analyzed testing data.

Wrote technical reports.

Presented results and analysis of testing data.

Process Engineer, Genentech, Inc, South San Francisco, CA

Jan. 2003 to Sept. 2011

Responsible for purchasing, installing, validating and improving equipment used in aseptic vial filling.

Lead Process Engineer that successfully installed a new technology to measure vials for raised stoppers. The project was on time, under budget and met its objectives. The total project budget was $1.5 million.

Made presentations on Raised Stopper Detection at the 2010 and 2011 Parenteral Drug Association Annual Conferences.

Lead Process Engineer for the start up of a clinical aseptic vial filling facility. This included the purchase, installation, startup and validation of vial washers, fillers, lyophilizers, depyrogenation tunnel and oven, cappers and autoclaves.

Supervised two contract engineers and worked with a vendor in the US and Germany to rebuild a vial washer. The project was completed on time, under budget and met its objectives.

Performed Right the First Time Engineering Design Reviews and Change Record assessments of changes to the aseptic filling equipment.

Facilitator of Biweekly meetings to coordinate projects for the clinical aseptic filling facility.

Lead a Total Product Maintenance team to improve the setup and operation of vial cappers.

Completed company training on Operational Excellence for Team Leaders. This includes DMAIC, Lean, SPC, DOE and a project that optimized a vial washer process that reduced WFI usage by 40%.

Co-Lead of the Safety Improvement Team. The team determined the appropriate response to safety suggestions.

Have experience on various aseptic vial filling equipment: Vial washers, depyogenation tunnel and ovens, fillers, lyophilizers. cappers, stopper processors and autoclaves.

Manufacturing Development Equipment, Agilent Technologies, San Jose, CA

1999 to 2003

Responsible for long term maintenance of photolithography, thin films and plasma etch equipment used in semiconductor wafer fabrication. This included writing capital justifications, and build and acceptance criteria. In addition, installed and brought the new machines online.

Lead Engineer of a $25 million upgrade of a wafer fab facility.

Coordinated the purchase, shipping, installation and startup of several plasma etch systems.

Analyzed Statistical Process Control (SPC) charts and wrote Out of Control Action Plans (OCAP) that reduced machine downtime.

Organized and ran monthly Pareto Meetings to determine ongoing problems and their solutions.

Wrote maintenance and departmental procedures.

Created a spare parts inventory for the machines.

Active member of several quality improvement teams.

Managed the assets for the semiconductor fab as the assets were transferred or sold.

ADDITIONAL EXPERIENCE

Senior Equipment Engineer, National Semiconductor, Santa Clara, CA

1996 - 1999

EDUCATION:

BSME (Mechanical Engineering), California Polytechnic State University, San Luis Obispo

Six Sigma Green Belt, American Society of Quality

Certificate in Project Management, UC Santa Cruz Extension

Certificate in Engineering Management, Santa Clara University

Company sponsored classes in Operational Excellence, cGMP, Design of Experiments, Statistical Process Control, Team Leadership, Failure Mode Effects Analysis, Root Cause Analysis, Cleanroom Procedures, Chemical Handling, Safety, Basic First Aid, Talent Selection and Google Docs.

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