Drive cross-functional communication and provide technical / project management expertise for the timely execution and closure of deviations, investigations, and lifecycle projects of external manufacturing sites for parenteral biologics drug products
Lead the successful implementation of ExM lifecycle projects
Work with cross-functional teams from external companies for successful procurement, implementation, and regulatory submission of business-critical projects
Tech transfer lead for new parenteral biologic drug product implementation at external site
Lead the procurement, execution, validation and regulatory submission for a new product in a sterile manufacturing line.
Collaborated with other departments to facilitate successful project completion.
Capital Project Engineer
ABBVIE, INC.
01.2019 - 01.2021
Assemble and lead effective cross-functional project teams in the scoping, procurement, installation and qualification of critical packaging equipment for pharmaceutical products
Spearheaded the scoping, planning and implementation of a new packaging line including facility upgrades and new equipment installation and qualification for the pilot launch of a parenteral device product (Skyrizi)
Responsible for project management of a portfolio of Capital Equipment Projects and programs of varying scope and complexity in a pharmaceutical GMP environment.
Packaging Value Stream Engineer
ABBVIE, INC.
01.2016 - 01.2019
Developed and implemented quality and performance-centered optimization projects for packaging lines to increase yield and reduce waste
Reduced false rejects on high-volume parenteral device packaging line by 1% resulting in annual savings of $200M
Lead and successfully implemented engineering upgrades to packaging lines in preparation for the introduction of new products
Spearheaded the introduction of brand-new Humira formulation to US packaging lines
Managed the installation and qualification efforts of a $1.5MM equipment for the secondary packaging of mid-volume syringe packaging line which resulted in an overall 15% Line Overall Equipment Effectiveness increase.
Trained and mentored junior engineers, providing guidance and direction.
Plant Process Engineer
AIR PRODUCTS AND CHEMICALS
01.2014 - 01.2015
Implemented real-time KPI monitoring for equipment performance and efficiency for over a dozen HyCO Plants
Introduced predictive-failure monitoring via historical performance data analysis and introduced a region-wide maintenance response infrastructure
Improved reliability and maintenance response to equipment failure by introducing live data-driven predictive maintenance scheduling.
Process Safety Engineer
AIR PRODUCTS AND CHEMICALS
01.2013 - 01.2014
Oversaw the implementation and upkeep of Hazard and Operability Studies (HAZOP) and various risk analysis tools for hydrogen manufacturing plants nationwide.
Senior Clinical Trial Assistant (Sr. CTA) at WE ARE INFINITE-Bristol Myers Squibb -MEXICO-COLOMBIASenior Clinical Trial Assistant (Sr. CTA) at WE ARE INFINITE-Bristol Myers Squibb -MEXICO-COLOMBIA