cjwimmer

7/15/2015
Raleigh, NC

Position Desired

Biomedical Engineering
Anywhere in the U.S.
Yes

Resume

EXPERIENCE

Associate Specialist, Engineering | Merck & Co. | Durham, NC April 2013 – Present
Investigation of deviations, process improvement and optimization.
Conducted investigations of pharmaceutical manufacturing deviations:
o Use Root Cause Analysis to determine root cause of deviations.
o Trending analysis, providing metrics on repeat deviations.
o Implement Corrective and Preventive Actions to reduce the deviation generation.
o Determine potential downstream effects and subsequent impact to product quality.
Use technical writing skills to communicate investigations according to GMP standards.
Interface with multiple functional teams: Operations, Technology, Engineering, and Quality Assurance.
Utilize GMP software such as MES, SAP, LIMS, PI, and DeltaV.
Hired Contract to Full Time October 2014.

R&D Engineer | Flexcell International Corporation | Hillsborough, NC January 2012 – April 2013
Product development of tissue engineering devices:
o Used SolidWorks to design products for rapid prototyping and injection mold manufacturing.
o Designed and executed mechanical and biological experiments to test development of products.
Managed production of equipment; includes assembly, calibration, quality control, and repairs.
Interacted with customers at trade shows and by providing technical support for products.
Authored user instruction manuals and technical reports.
Awarded at NCTERMS 2012 for abstract: Novel Wound Tear Model for 3D Bioartificial Constructs in vitro.

Intern | Flexcell International Corporation | Hillsborough, NC June 2011 – January 2012
Learned tissue culture techniques in order to grow and maintain human tendon cells for bioartificial tendon research. Including good laboratory practices, sterile technique, media formulatio...

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