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Yyyyyy x. yyyyyy

Urb. Mansiones del Caribe Xxxxxx, PR xxxxxx xxx-xxx-xxxx


Dynamic, detail-focused and enthusiastic Engineer with years of progressive and diversified experience, paired with a strong educational foundation. Possesses experience in the biotechnology, medical device, pharmaceutical and water/sewage industries. Adept in driving company goals that bolster success levels and drive organizational efficacy. Thrives in deadline-driven environments that call for adaptability and flexibility. Seeking a challenging and exciting new role with a company that is poised for growth.


Key Areas of Knowledge & Expertise


Project Management Strategic Planning Engineering Operations Leadership & Teamwork Goal Setting

Interpersonal Communication Organization Time Management MS Office & SharePoint Windows OS SAP


Professional Experience


AMGEN: Process Development Engineer (2016-Present)

         Characterize packaging machinery according to new FDA requirements for packed biotechnology products as part of a larger serialization project

         Lead process development for Intelli-Code and Intelli-Pack machines with precision and attention to detail


Validation Engineer (2013-2015)

         Focused on maximum vial production over the course of a vital start-up initiative; worked as a QC sampling management subject matter expert (SME) to support characterization efforts

         Drove Cleaning, Clean in Place (CIP), Steam in Place (SIP), Equipment and Process characterization processes

         Fueled the gross of the project to be concentrated on testing automated equipment in order to find optimal performance best practices


CR-BARD: Advance Manufacturing Engineer (2015)

         Maximize production on a medical device line via the performance of both an IQR and a OQPQP

         Crafted inspection and manufacturing procedures and performed each with timeliness and thoroughness

         Leveraged change controls in completing auditable documentation


NOVARTIS: Validation Engineer (2013)

         Spearheaded a Risk Management project within a manufacturing and packaging environment

         Worked as an internal Technical Auditor to assess the quality risks of the process could, thus starting CAPA exercises before validation activities commenced in order to comply with all applicable regulatory agencies

         Devised manufacturing process flow diagrams to identify critical process parameters and steps and guarantee watch was performed with a focus on excellence


MERCK: Validation Engineer (2012-2013)

         Effectively maximized production for an oral vaccine manufacturing facility

         Acted as a SME relative to thermal validation equipment and thermometric data analysis, including advanced statistics and trending, all provided for process development and validations

         Served as a liaison during project management meetings; provided updates including schedule modifications

         Executed sampling management efforts, e.g. swabbing techniques, biological indicators and materials preparation, in conjunction with the QC Laboratory

         Developed cycles and validations on live virus manufacturing equipment, e.g. incubators and part washers

         Performed isolation technologies with autoclaves, refrigerators, tanks and culture media transfer lines


JANSSEN: Project Manager (2012)

         Crafted and executed projects on demand along with other special initiatives as requested

         Determined a need for a quality database information source to apply system analysis designer techniques; performed source approval for the software life development cycle (SLDC) upon receipt of final approval

         Led department activities using SharePoint to deliver updates and make modifications within an organized, proactive and focused department group

Yyyyyy x. yyyyyy



JANSSEN: Project Manager (Continued)

         Headed a Special Manufacturing Meetings Conference Room Project using a DMAIC techniques approach, which allowed for heightened levels of communication among departments

         Designed and created innovative presentations for Directors within the confines of a global division group

         Worked as a liaison to attend management meetings and offer status, schedule, analysis and support updates as a Project Lead

         Drove short-term manufacturing and packaging projects; offered holistic support and mentoring to managers in the process

         Offered expertise on work measurement and scheduling evaluation to fuel projects viability and success


AAA Water and Sewer Authority: Project Manager (2009-2011)

         Reported to CEO; developed and managed a $2M budget used to invest new development programs

         Played a key role during service program sales functions and organizational meetings

         Implemented culture changes across 1200 program employees using training focused on change management and challenge

o    Efficaciously implemented program at 27 cities

o    Managed all project elements including schedule, budget and resources

o    Also handled tasks including corporate business development and human resources functions

         Supervised, coached and trained Corporate Schedulers and Coordinators, along with Client Maintenance Supervisors and clerical personnel

         Worked intensively with the Reliability Analysis Manager, Technicians and Software Developers to design, create and introduce an internet module for analysis, planning and scheduling that helped the company tend to client needs

         Identified actual processes using Six Sigma DMAIC strategies, a direct result of a newly-made maintenance program

         Worked as a Planner/Scheduler to identify custom needs and analyze requirements to perform structured, effective maintenance

         Served as a System Design Analyst to craft a Planning and Scheduling Module based on an internet platform

         Also created all documentation, processes, metrics, training, presentations, filing strategy, etc. for the new Emerge program


McNEIL: Project Coordinator (2007-2008)

         Worked as a member of the Process Excellence team to lead manufacturing projects such as the Hand Truck Optimization Project , Gel Dipping Cutline Adjustment , Waste Chaser Strategy and other Kaizen and small projects to drive cost savings

         Provided support as a SME on Six Sigma DMAIC strategies that heightened the flow of on-site continuous improvement projects

         Also completed batch record changes and change control management efforts as needed

         Managed manufacturing and packaging of WIP Destruct Orders System & Signatures Manager due to inventory suffering a significant change that demonstrated savings via material handling reports

         Represented Site Safety Procurement & Logistics Department staff meetings and relayed minutes to Director

         Was the Materials Buyer for the manufacturing and packaging warehouse; handled purchasing for all items needed departmentally or per project

         Served as an Inventory Logistics Agent to process work-in-progress manufacturing bulk transfer on fiber drums


Also worked as a Facilities & Utilities Maintenance Supervisor with Janssen from 2005 2007




Bachelor of Science, Industrial and Management Engineer, Turabo University



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