Engineer Six Sigma

Alexandra M. Col n Bonano

*** ****** ******, ******** ****, San Juan, Puerto Rico 00924

Phone 787-***-**** . *********.*******@*****.***

Industrial Engineering Profile

Successful in the development and optimization of metrics and processes to

directly improve quality and monitoring of the production processes in

place in the pharmaceutical industry.

Increase the effectiveness, quality and productivity of manufacturing

process through the design and analysis of processes components and

metrics; significantly improving the efficiency of operations and creating

an efficient metrics system to monitor the process areas accurately.

Quickly and accurately identify opportunities for preventive actions to

address manufacturing constraints while addressing management concerns.

Surpass project expectations by completing projects with aggressive

timelines while complying with quality requirements. Proficient in the use

of productivity tools such as Word, Excel, Power Point, Project, Visio,

Minitab, Statgraphics, Trackwise and basic knowledge of SAP. Outstanding

skills in communication, problem-solving, relationship management and

excellent teamwork and the ability to employ these skills to drive for

results. Speak and write both English and Spanish fluently.

Areas of Expertise

Lean Manufacturing - Six Sigma - Root Cause Analysis - Standard Times

- Audits - Statistical Process Control - Metrics Design

Professional Experience

VALIDATION SPECIALIST 8/2008 -Present

Validation Engineering Group - Catano, Puerto Rico

Provide consulting services in the design, management and creation of

metrics for the productivity and six sigma departments at a major

pharmaceutical company. Perform and manage metrics database for different

departments within a client, while performing bi-annual audits of different

products recipes and process times involved. Revise product standard times

to comply with volume demands, manufacturing and packaging plans and long

range plans. Prepare statistical analysis for manufacturing investigations

and provide results that are clear to management. Provide metrics advice

and support to manufacturing and packaging team leaders relating to their

tasks.

Selected Contributions:

. Design and create a Quality Scorecard to monitor department's

performance complying with their investigations and quickly identify

causes related to productions deviations. The tool impulse six sigma

projects covering a 32% of the projects required for 2009. The project

is been replicated in other Lilly sites US, Spain, Brazil and Mexico.

. Collaborate with senior management on Cymbalta 32% dissolution

statistical problem solving analysis identifying successfully the root

cause and not having any further problems on product process

performance.

INDUSTRIAL ENGINEER 10/2006 - 3/2008

Wyeth Pharmaceuticals Company - Guayama, Puerto Rico

Main responsibilities include the management of Master Batch Record Changes

(MBR) which led to Manufacturing Process Changes. These changes were

performed while maintaining full compliance with all commitments related to

the primary processing unit of Effexor XR. Actively support and manage

changes to the MBR's to align them with the upcoming Electronic MBR System

(E-MBRS). Create the Pictorial (MBR) for the three doses manufactured and

translate from English to Spanish improving the operation execution by

operators. Prepare yield comparison reports according the production of

Effexor XR Capsules. Designed a job performance-tracking database which

tracks and presents in a user friendly graphics the changes and identify

trends in performance errors. Form part of the new Cleaning Log Book (CLB)

development process to improve the quality of the documentation retained of

the manufacturing equipment cleaning process and proper retention policies

in order to comply with FDA regulations.

Selected Contributions:

. Master Batch Record project led an improvement of the manufacturing

process and a dramatic reduction of job performance errors up to a

30%.

INDUSTRIAL ENGINEER INTERN 3/2006 - 10/2006

Pall Life Sciences - Fajardo, Puerto Rico

Design a Headcount and Capacity tool to determine the headcount needed to

meet with yearly demand. The tool is based on time studies performed on

four product families and capacities depending on present demand.

INDUSTRIAL ENGINEER INTERN 11/2004 - 2/2006

Cristalia Premium Water - Ponce, Puerto Rico

Executed the Facilities Design Project, redesign the parking, cafeteria and

relocate departments inside the facility. Implement visual management to

improve the safety and management of the inspection of the 5 gallon water

bottles. Performed a Job Study on 1 gallon water bottle packaging process

to detect if process and employees task run on time and efficiently.

Education and Credentials

Master of Science in Manufacturing Engineering (2010)

Polytechnic University of Puerto Rico - San Juan, Puerto Rico

GPA 3.11

Bachelor of Science in Industrial Engineering (2007)

Polytechnic University of Puerto Rico - San Juan, Puerto Rico

GPA 3.87

Professional Development

Principles in Lean Manufacturing

Six Sigma Green Belt

Design and Implementation of Statistical Sampling Plans

Train the Trainer

Root Cause Analysis

GMP Guideline Practices

Memberships and Associations

Institute of Industrial Engineers (IIE) 2004 - present

American Society for Quality (ASQ) 2008 - present

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