Engineer Project

Alexander (Alec) R Smith

**** * ******** **

Phone: 419-***-****

Bloomington, IN 47403

e-mail: ***********@*****.***

WORK EXPERIENCE

July 2011 - Present

Cook Inc.

Bloomington, IN

Validation Engineer

. Project leader for validation remediation effort in response to an FDA

warning letter. Team of 21 completed over 230 process validations

within 3 months.

. Responsible for initiating process improvement projects for material

bonding, including equipment improvement and processing changes to

improve efficiency, reduce reject rate, and improve quality.

. Routinely interact with multiple disciplines within the corporation

(operations/marketing/regulatory/quality)

. Led validation activities, including IQs, OQs, PQs, and DOEs in 11

different departments.

. Responsible for compiling all statistical analysis of data involved

with the validations completed as well as writing protocols, reports,

design of experiments, and investigational study documents.

. Completed over 25 full process validations, beginning with process

investigations, and improvements up to final implementation of the

validated process.

. Completed product line transfers to a new manufacturing site, while

simultaneously conducting processing improvement implementation and

validation for the catheter product line.

October 2009 - July 2011

UCB/Kremers Urban Pharmaceuticals Inc.

Seymour, IN

Validation Specialist

. Reviewed and approved computer system validations on all GxP systems

on site.

. Reviewed and approved process validations for new products and

processing changes.

. Worked on the validation and integration of a global SAP system.

. Worked on the implementation of electronic batch records.

. Conducted process, packaging, and cleaning validations.

Aug 2006 - May 2007 and May 2008 - Aug 2008 (returned to classes in the

intermediary)

Boston Scientific Inc.

Spencer, IN

Process Engineer Co-op

. Participated in validation remediation project in response to an FDA

warning letter.

. Developed test methods for in-processes verification testing and

validation testing

. Conducted test method, product, and process validations (IQs, OQs, and

PQs)

. Assisted in design and development of product/process improvement

techniques

EDUCATION

Graduated May 2009

University of Toledo

B.S. in Bioengineering

. Senior Design Project - Created and marketed "Quick Release Tubing"

for insulin pumps.

CONTINUING EDUCATION

Additional Training

. Participated in animal testing of products

. Computer Validation System conference IVT 2010

. SAP introduction training

. Creo training

. Root cause analysis training

. Machine shop introduction training

ADDITIONAL SKILLS

Computer Programs: Mini-tab

StatGraphics Centurion

Solid Works

Creo

SAP

Livelink

Office Suite

Other: Simple soldering

Tig-Plasma Welding

Machining (mill, lathe, drill press)

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