Employ control and authorization over the global customer produce labeling system management and produce labeling systems engineering design.Lead all aspects of produce labeling systems manufacturing, overall system reliability improvements, and new product development.Implement measures to improve supply chain/purchasing management of OEM product and process engineering design of label material.Preside over global customer site operations and customer installation site territories across the California Region, US Northwest, Texas, Kentucky, Canada, Mexico, Chile, and Peru.Oversee 20 engineering employees, including Supply Chain Manager, two Process Engineers, and 17 service technicians as well as the overall inventory control system.Lead CAD engineering design for facility layout planning utilizing AutoCAD and OEM labeling system engineering part design in SolidWorks CAD. Headed an eight-person sub-contracted Electrical Engineering team for proprietary high-speed printing firmware and PCB development. Achieve an industry-leading print-on-demand speed increase from 11 label dispenses per second to 14 and continuous labeling capability of 14 labels per fruit/lane per second.Headed a sub-contracted Mechanical Engineering design firm throughout a system reliability improvement and successive rotating label applicator development project. Decrease system COGS in an inflationary economic climate by relocating part fabrication overseas. Review, assess, and modify various sub-components for the purpose of moving to injection molding vs. traditional fabrication. Realize a cost reduction of 65% per individual part and a 35% overall system COGs reduction.Tech Transfer the print technology and labeling system design to a partner company in Israel at the end of a 10-year design process.

Demonstrated expertise in leading commercial high volume manufacturing operations in the Shire Los Angeles Fractionation Business Unit which operates 24/7 and consists of five shifts and 80 employees. Integrated a Lean Management System (LMS), including tiered visual systems, manufacturing process standard work, 5S, DMAIC problem solving, and rapid response. Commended as the best in the Shire corporate network for manufacturing process standard work.Collaborated with stakeholders throughout the development of a five-year strategic plan for a 1,000+ employee manufacturing site utilizing the Hoshin Kanri planning system.Ensured full compliance with safety procedures and deviation free processing while meeting manufacturing production forecasts and maintaining a $10 million department budget.Administered independent manufacturing process suites with a processing rate of over 150,000 plasma units per week.Headed a facility ramp-up from 3.3 million liters to a run rate of 3.8 million liters in one year with a reduction in process variation and cycle times and a 10% decrease in process cycle time.Piloted the implementation of a new Shire network equipment reliability strategy and department cultural change.Lessened cost of goods by 15%, improved 12% deviation free processing by 12%, and enhanced safety compliance with 0 SIFs (Serious Injury and Fatality).Boosted process yield recovery by 8% from 2017 for highest yield recovery by 2018.

Provided tactical leadership throughout Quality Assurance and Quality Engineering efforts for the start-up of a new, state-of-the-art automation controlled protein purification facility.Leveraged prior manufacturing experience and manufacturing process knowledge as a key Subject Matter Expert for a tech transfer of 2 product lines to the protein purification facility.Oversaw 12 Quality Assurance professionals accountable for conducting critical activities, such as CAPA investigations, batch record review, and subsequent product release.Served as FDA/EMA subject matter expert for multiple AHF-M NF/Flexbumin quality assurance subjects. Operated as Quality Assurance Representative during all FDA/EMA production floor walk-throughs for AHF-M NF licensure inspection and Flexbumin post-licensure inspection.Utilized strong technical knowledge in column chromatography and various protein purification filtration steps (UF/DF/Nano).Functioned as Quality Approver for product/non-product impact CAPA investigations as well as QA Change Control Approver and Document Change Management SME.

Directed and oversaw all AHF-M manufacturing operations, consistently leading the AHF department in production optimization and ensuring the highest level of end product quality.Appointed with managing mandatory overtime for 15 months for reporting manufacturing technicians due to production demand increase of 20% in 2014 and an additional 10% in 2015.Developed and promoted out of the shift with approximately 50% of shift employees employed for less than 12 months. Promoted high performing headcount for transfer into new manufacturing facilities.

Manufacturing Development Program offered a rare experience to learn 2 Business Units consisting of 3 departmental rotations. Program focus was to learn the manufacturing processes from a technician point of view on the manufacturing floor over an accelerated time frame.

Provided critical Fire Protection and Mechanical Engineering Consulting Support to Tennessee Valley Authority: Browns Ferry (BFN) and Bellefonte (BLN) Nuclear Power Plants to best prevent power plant system failure in the event of a fire or other emergency.Direct oversight of 3 Associate Engineers.Proficient in reading mechanical, P&ID, electrical, civil, and other technical drawings to provide mechanical engineering expertise used in BFN and BLNs transition from existing deterministic safe shutdown analysis to the newly proposed alternate NFPA 805 standard.