Highly analytical, performance-driven engineering professional offering experience in quality engineering, process improvement, process development, calibrations, maintenance, technology transfers, and validations.
Professional Experience
Hospira – Austin, TX (July 2012 – Present)
As Technical Professional Development Program (TPDP) Engineer, I am responsible to understand the operations and quality through exposure to multiple areas within Hospira’s Pharmaceutical Operations organization.
Manufacturing Science and Technology (MS&T) (July 2013 to Present)
o Supporting the site to site technology transfer of Hospira products to Austin
o Assisted and contributed to the exhibit runs and validations runs for technology transfer
o Initiated and drafted a Product Change Request to modify and update product specifications by collaborating with key players and subject matter experts
o Provided supporting information for regulatory submission of the technology transfer
o Currently designing, developing, validating, and implementing a lab bench heat exchanger to cool down samples for chemistry testing, reducing lab test time
o Implementing and validating the tracking and trending of incoming API test results for basic statistical process control and analyses with InfinityQS
o Support the statistical analyses of periodic reviews of equipment utilized in the plant
Calibrations (August 2012 to June 2013)
o Supported FDA 483 Observation until closure
o Closed out Exception Reports and implement Corrective Actions/Preventive Actions
o Revised calibration procedures and formatting for better understanding
Maintenance (July 2012 to June 2013)
o Completed a plant shutdown project, $50K cost avoidance
o Managed and budgeted capital and expense spending of plant shutdown project
o Developed timelines and collaborated with vendors to implement installations
o Initiated and drafted Validation Change Requests through completion
o Facilitated meetings to improve preventive maintenance procedures for clarity and efficiency.
Additional Professional Development Experience/Knowledge
o Six Sigma & Lean Quality – Pending Greenbelt
o cGMP
o Investigations – Closed out multiple exception reports and
o Change Control – experience with local and corporate change control
Education
Bachelors of Science in Chemical Engineering, December 2011
The University of Te...
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