• Managed the site expansion and transfer of product lines from a 20k square foot manufacturing facility to an 80k square foot cGMP facility with a top of the line ISO7 cleanroom, satisfying the needs of the biopharmaceutical and medical markets. ISO 13485, ISO 9001, ISO 14644-2, ISO 14001• Drove the acquisition of capital equipment to meet the demand of a rapidly growing industry (25% growth rate in 2020), while providing capacity for future business development• Managed and developed a team of engineers by organizing objectives and timelines for the implementation of new manufacturing equipment, and coached them through obstacles with minimal impact to the deliverables• Integral part in the development of future budget – projects geared to reduce costs, increase capacity, increase margin, and deliver more robust products to the customer• Technical consultant during customer complaints/inquiries/audits – direct contact with customers to explain the process or root cause analysis, or explain the resolution to their issue/question• Leading the installation of 4 x 6,000gallon mineral oil silos with PLC/server connectivity for dispensing of raw materials into the blending department. Coordinating EHS, Facilities, Maintenance, Engineering, and local/state activities• Championing multiple outside the box projects that will position the business well for forecasted and unforeseen demand

• Managed the World Class Manufacturing (WCM) Reliability Pillar. Developed a plan to implement predictive maintenance technologies, that included IoT technologies for server based monitoring of vibrations, heating/cooling, and lubrication. Developed a skills matrix and growth plan for maintenance professionals, which ultimately identified the gaps that we needed to fill• Developed the structure for coordinating projects and decision making tool for selecting project priority. Reduced resource constraints and allowed for faster completion of high return projects• Coordinated engineering activities as they pertained to the expansion and efficiency of the manufacturing of the C-Flex and Bio-Simplex product lines. Reducing setup times following SMED principles. Lead Kaizens to eliminate downtime due to repetitive short stops, updating clean/inspect/lubricate protocols to increase Mean Time Between Failures, and decrease Mean Time to Repair again following a similar SMED philosophy• Developed and mentored new engineers, while supporting the growth of current staff• Supports the production process by alleviating manufacturing process losses through implementing capital projects, troubleshooting, and personnel training• Manages and supports capital procurement, IOPQ equipment and process validations, Corrective and Preventative Actions (CAPA), and maintenance related projects and change orders

• Supported the production process by alleviating manufacturing process losses through implementing capital projects, troubleshooting, and personnel training• Manages and supports capital procurement, IOPQ equipment and process validations, Corrective and Preventative Actions (CAPA), and maintenance related projects and change orders• Managed maintenance activities, and transitioned duties to new supervisor upon hiring. Preventive and reactive maintenance scheduling. Spare parts management.• Implemented and validated (Installation, Operational, and Performance Qualification) of a new Computerized Maintenance Management System (CMMS) that Complied with the 21 CFR Part 11 requirements of the Biopharma industry• Integral in the plant achievement of being awarded WCM Bronze status• Managed the WCM Reliability Pillar

Summary:Provided support to the International Space Station (ISS), Ground Systems Development (GSDO) and Operations, Space Launch System (SLS), Orion Mulit-Purpose Crew Vehicle, and Launch Services Programs. Support to the aforementioned programs included, but was not limited to,• Provided technical support pertaining to material selection, process analysis and improvement, and failure analysis. Materials ranged from chemicals, metals, films, adhesives, lubricants, and other commodities. Processes supported include metal working, lubrication systems, chemical conversion coatings, inventory and shelf life control, and more.• Supported Reliability Centered Maintenance by proactively assessing asset conditions and preventing issues before they arose. • Performed laboratory testing to verify material characteristics, trend material condition, and to extend the shelf life of commodities to avoid unnecessary cost and waste.• Reviewed and approved engineering drawings for material specification compliance.• Participated in and led cross-functional teams to resolve high profile issues – included root cause and process analysis, test protocol design, and implementation of resolutions or improvements.  Prepared reports and presentations delivered to upper level management, Engineering Review Boards, and NASA counterparts.

Worked on a couple of projects focused in the area of "Novel drug delivery systems by tablet technology: Repositioning the FDA (Food and Drug Administration) approved drug pipeline". We have successfully combined 2 FDA approved drugs into a single tablet while reducing the rigors involved with manufacturing high drug load therapies. This new combination will also reduce the amount of tablets to be administered to the patient, thus increasing patient therapy compliance.

Summary:Was responsible for internal and external communications between different sites, vendors, customers, and onsite staff to develop innovative thermoplastic elastomer compounds, statistically determine the process capabilities of design inquiries, optimize current processes to cut down on process time and material waste, and was involved with root-cause analysis of internal and external product failures or concerns. Other duties included, but not limited to,• Product and process validations by performing installation, operation, and performance qualifications (IQ, OQ, PQ)• Utilized Six Sigma tools to conduct process capability studies, Gage R&Rs, process control, and more.• Performed shelf life studies, design of experiments (DOEs), product specification compliance testing, and more.• Conducted process, product, and design FMEAs.• Supported the manufacturing, production, quality, and sales teams with varying issues in support of the company and the company’s customers.• Presented project updates, including financials, test results, roadblocks, and customer feedback to upper management at Stage Gate steering committee reviews.