Jomar Hernandez, Cqe Email and Phone Number

Acting Associate Director leading the Plant Quality Assurance organization at the Aseptic Formulation and Filling facility. Lead a team of 4 Quality Managers with an extended organization of almost 40 specialists and associates covering a 24/7 operation.

Manage a group of 9 people for a Combination Product Packaging Line. Successfully developed an evolving shift structure that went from 8x5 to extended shifts of 12x5 and 12x6 to support increasing demand of the product. Developed a group of additional 9 resources to implement a second shift increasing manufacturing capacity. Developed staff to maintain high performance and increase business acumen. Used previous technical experience to guide the team to problem solving mentality and to support technical services and engineering teams in equipment troubleshooting.Starting on January 2020 transferred to a new Combination Product Line supervising manufacturing operations with a group of 7 regular staff and 4 contingent workers.

Engineering technical contact for a Fully Automated Combination Product packaging line with two different product presentations. Engineering technical contact for the new automated inspection machine with capability to inspect syringes and cartridges. Responsible for line OEE metrics and data evaluation leading toward a 10% improvement on the metric. Supported the FDA pre approval process and launch of a new combination product for the packaging line.

Process Owner for Manual Inspection Process within the packaging organization. In charge of inspection processes and techniques.

Provide Line and System Owner support to Vials Filling process composed of two Filling Lines. In charge of preserving Validated State for equipments such as West Washers, West Depyrogenation Tunnels, West Capper, Inova Filler, Bosch TL Filler, Bosch Trayloader and Bausch + Strobel Capper. Develop Maintenance Job Plans, Operational and Mechanical Procedures and Training Qualification documents. Own and manage area improvement projects, Corrective and Preventive Actions, Change Controls and Nonconformance Technical Assessments. Perform Asset Management on Computerized Maintenance Management System (Maximo CMMS).

As a Senior Engineer I work for the Plant Engineering Department whithin the Operations Organization on the Fill and Finish plant on Juncos Puerto Rico. I started as the Component Preparation area Line Owner in charge of the Cleaning and Sterilization Operation Overall Equipment Efficiency (OEE). Shortly after that, I was reassigned to the same role for the Vials Filling Operation which I performed for a year after which I was reassigned to the System Owner role for the Vials Filling Operation. At this current role, I'm in charge of preserving Validated State on all Fill and Finish equipment within my area. Among the equipments I own are West Vial Washer and Depyrogenation Tunnel, Bosch TL Filler Machine, INOVA Filler Machine, Bausch & Strobel Capper, West Capper, Bosch Trayloader, Inspection Systems such as Vitronic and Cognex. Author and owner of most technical documents related to the Vials Filling Process. Own and manage most of the Equipment Related CAPAs and Change Controls for the Vials Filling Process. Author, manage and/or review maintenance Job Plans and Work Orders for the Vials Filling Process.

Lead and Support activities related to the final transfer and manufacturing start up of new developed product platforms and manufacturing technologies. Perform equipment development, characterization, validation and implementation of new manufacturing automated technologies and robotics. Support scrap cost and operational cost reduction initiatives.

As part of my Process Development Engineer role in Caguas, Puerto Rico I was assigned to several key projects within the organization. Served as Project Manager for capacity improvement initiatives whitin the plastic components forming area. Served as plant SME for inspection qualifications and Gage R&R methodologies. Provided statistical consult to PD engineering group. Latest project assigned to me was to served as the Caguas facility main contact for next generation device project. As part of this project I was relocated to Minnetonka, Minnesota facility to integrate the team that was developing the device. Among my assignments was to understand the device from conceptualization and R&D into Manufacturing. Provided technical inputs to assure equipment design was robust enough to support High Volume Manufacturing in Puerto Rico. Provided support to the product manufacturing start up in Minnetonka and product launch within the US. Supported the product and equipment transfer to Puerto Rico facility.

As Quality Engineering Technican I was in charge of the quality metrics of one of the Busines Units. Performed periodic reports containing line performance in terms of Yield, Defects per Million Opportunity and First Pass Quality. Served as the team Subject Matter Expert (SME) for Optical Comprators (widely used at components inspection areas among the company). Served as the department SME for Gage R&R and Attribute Agreement Studies. Served as part of the team implementing Statistical Process Control initiative on the facility. Develop applications to automate the data collection of several automated system into the SPC Package for data monitoring. Provided statistical support to Manufacturing Engineering Department. Provided direct support to technology transfer projects serving as backup quality contact to the QE in charge and as main contact for technical aspects of the transfer as the installation, validation and implementation of a Humidity Sensor to monitor the dew point on the areas were the product was exposed.

Relocated to the Cardiovascular Division Vascular Closure Business Head Quarters; Support the development of the new Vascular Closure product platform technology from R&D to High Volume Manufacturing. Lead and Support cross-functional, cross-divisional teams in the design, development, manufacturing, characterization, validation and implementation of new automated equipment technologies and robotics for building the new product platform. Performed live Risk Assessment for the developed processes using the Process FMEA tool.

Served a Plant SME for Inspection Qualification and Gage R&R methodologies supporting projects resulting on head-count reduction and cycle time improvement. Performed equipment transfer and validation to support manufacturing capacity increase. Lead cross functional, cross divisional team to assess current manufacturing technologies and provide recommendations to Engineering Directors in order to make improvements for further equipment or technologies development.