Qualification Summary
•Excellent communication and inter-personal skills
•Performs effectively despite changing deadlines and priorities
•Ability to identify, analyze, and solve problems
•Reliable self-starter; can be depended on to complete assignments on time and within budget
•Demonstrates competence in working with others in a cross functional team effort
•Collaborate with co-workers at all levels, as well as proven individual contributor
Work Experience
Circle Graphics, Longmont, CO, September2013 to Current
Circle Graphics' Consumer Digital Printing (CDP) division is a world-leading inkjet printing and custom art production site. Circle Graphics’ CDP division provides marketers of wall décor, art reproduction and professional photographers with the lowest-cost high-resolution digital printing services in the industry. Our unique service enables art and photography professionals to fundamentally eliminate inventory and transform their businesses to a uniquely competitive print-on-demand production model.
•Manufacturing Engineer
o Designed and implemented a new layout for shipping on single packaging line. This project included line design, equipment design, equipment purchasing, line set-up, procedure updating, and training.
o Restructured consolidated shipping and defined consolidation control limits to improve shipping costs. This was comprised of assisting in the redesign of the software systems used to consolidate product shipments, detailing the process flow of information, development of reports, floor layouts, training documents, and testing the new systems when implemented. While the main focus was on cost reduction, there were also ergonomic and safety concerns that were addressed with the implementation of this program.
o Managed the release of new product line. This encompassed design review and testing custom equipment, fixtures, and processes released by Research &Development. In most cases it included facilitating the modifications of equipment and fixtures and restructuring the process to improve performance. Process review included preventative maintenance procedures and adjusting them to fit the demands and needs of the product.
o Developed key processes in evaluating in-house ink development that allowed for on-going manufacturing and maintaining equipment and quality control while conducting tests.
o Evaluated yield issues and determined the root cause for product defects. Assessed equipment design and operation procedures and established new methods of cleaning and preventative maintenance to improve yields by over 60% and product quality.
o Lead project to establish equipment ID’s for all equipment. This allowed for better tracking of equipment through its life cycle, improved management of PM’s, and quicker response times equipment work requests.
Novartis Consumer Health, Lincoln, NE, August 2011 to May2013
Novartis is a worldwide pharmaceutical company operating in over 150 countries around the world. Novartis is an FDA regulated company that manufactures prescriptions and over-the-counter drugs such as Excedrin, Triaminic, Maalox, Voltaren Gel, and many others.
•Qualification/Validation Engineer
o Lead qualification projects while working with cross functional teams. Ensured that projects were implemented in accordance with the agreed scope and time lines and goals were met.
o Reviewed and developed all qualification documentation such as the Qualification Plan, User Requirement Specifications, Functional Requirements, Design Documentation, Installation Qualification/Operation Qualification and associated test scripts and acceptance criteria.
o Execution of qualification projects and documents where I was not the lead on nor personally authored.
o Analyzed protocol test results and created the presentation of conclusions and recommendations to upper management.
o Completed Computer Systems Validation on the Kaye Validator Systems following 21 CFR part 11. The Kaye Validator System was used to conducted temperature and RH mapping in the qualification of Stability Chambers and Freezers.
o Supported cleaning validation efforts by leading daily meetings, providing training to new methods and protocols, being a liaison between operations, quality, and engineering support.
•Process Engineer
o Supported start-up efforts for Voltaren Gel when the product went from a prescription drug to an over-the-counter medicine. Evaluated existing equipment and lead projects to update and/or replace critical process components. Redesigned flow and how raw materials and finished units traveled to and from the production line. This project also included the manufacturing of the medicine at a separate location in the facility, and making this process more efficient by the way raw materials were staged and relocation of PLC’s closer to the process.
o Organized remediation plan for receiving bulk liquid materials. Redesigned the receiving area by creating a pass through for hoses to be cleaned in a clean washout room without the need to take them outside. Also wrote Standard Operating Procedures for the new process and trained to the procedures.
•Corrective Action Preventative Action (CAPA) Engineer Process Specialist
o Investigated unplanned deviations and assessed their potential impacts. Deviations and potential impacts had to be thoroughly and accurately investigated and effected product had to be dispositioned quickly to ensure regulatory compliance in product efficacy.
o Managed multiple investigations in different stages of the investigation at the same time. All investigations were closed on time to comply with FDA mandates.
o Conducted root cause analysis of unplanned deviations and implemented corrective actions and pr...
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