Establish new group to support the sites validation procedures, new system introduction, system changes, CIP, SIP, and periodic validation of all GMP impacting systems on the California campuses.

• Lead the creation of three key groups that directly interfaces and supports multiple manufacturing sites. Site manager for three groups (Asset Lifecycle Management group, systems qualification team, and data historian application owner). Included extensive internal and external recruiting, training and R&R defining within our organization.• As Novato Site Manager of the GMP qualifications team, have worked with global and local leadership to transition ownership of all IOQ, PQ, Re-Validation, and verification activities to our group. • US Manufacturing lead for the global asset lifecycle program development and deployment. Chartered best practices based on industry standards and site specific business needs. Lead our sites transformation from a 2017 ALM standardized assessment score of 3.3/10 to a 2020 score of 8.8/10 with sustainable programs and fundamental improvements, creating our manufacturing reliability vision.

Leader of CAPEX Automation Projects Group. Lead the creation of the new Automation Projects group. The team scopes, budgets, resources and executes CAPEX projects for California GMP manufacturing sites.

Manufacturing Automation systems engineer.

Leading ME2 reliability program for Pharmaceutical Manufacturing plant. Includes Full equipment assessment and prioritization for FMECA based improvements to parts stocking, PM's and data justification for design changes. Scope includes Equipment and Facilities equipment. Utilizing CMMS data, OSi-Pi Data and OEE data systems to evaluate improvements and investments for high volume regulated industries.• • Supported Site computer systems risk assessment for all factory systems. Directly responded to assessors, provided evidence, and current system state support. Coordinated cross functional response plan, and wrote, reviewed, or implemented actions in my area. Examples included disaster recovery, obsolescence planning and GMP backup and recovery plans. • Coordinated Technical team for recruiting, training and managing expanding coop program. • Define and implement the OSi-Pi data collection system by benchmarking with corporate strategy and leveraging Center Of Excellence practices. Evaluated the equipment for equipment OPC connections, planned, budgeted and completed the connection of first phase equipment. Tested and modified networking parameters and hardware. • Interim Supervisor for Tech Services 4 months• Electronic batch record design- Performed extensive Quality Parameter and current SOP configuration for coating area, compression area, and granulation. Lead Kaizen style meetings with key partners in quality, operations, and process engineering to design our electronic batch reports for ease of use, understanding and process flow that matches both the written MBR and the work flow itself.

Lean Design Engineer for capital expansion projects related to new product introductions. Design projects include full process mapping, data review, quality and compliance work flow, product isolation, sampling requirements and many user feedback continuously.Projects designed and completed included * Automatic Tablet testing integration into the software and process.* Washroom facility design for isolation, clean to dirty flow, and process optimiztion.* Tablet Coating systems full modernization of controls, and spray technology. Project performed using the data driven, design out philosophy to reduce changeover and reduce compliance risks. Easier to clean, faster loading and unloading and extensive industry partnering for current designs.* Compression suite design for flow. Included product flow, clean flow, and integration of equipment into the facility space.• Control system failure investigations for Windows, Honeywell, Allen Bradley and other OEM custom control modules. Complete the initial review, coordination of cross functional conversations for risk, bracketing, recovery, root cause, and CAPA write-ups. • Write and execute test plans for the validation of equipment control system upgrades relating and membrane coating. Protocols include FAT, SAT, IQ, OQ and PQ. FDA and EU audit support. Internally certified Deviation and Investigation support team. Pro-Model software trained and experience using model based evaluations for Capital spending plans.

• Leader of site reliability plan for 2011, key deliverables included asset care program for the Solids business unit, lifecycle asset replacement strategies and capital planning, 5S principles, documented quality job plans and incorporating key GMP practices into periodic cross functional area reviews..• Shutdown Coordinator for site facilities and equipment shutdown 2008.• Day to day support of factory and facilities equipment control systems, including, on-call and off hour phone support and on-site response. Passwords administration, system backup and recovery. Hardware system troubleshooting and repair of PLC and Windows based control systems.

• Lead Dry Etch group for major factory upgrade. Supported technical and logistics for over 25 capital system installations, while being sole install and qualification engineer for 10. o Verified operation image with production and process, defining layout to achieve maintainability and safety requirements. Defined, purchased, and performed upgrades for refurbishment and enhanced process capabilities. Defined all facilities and startup protocols for process validation. Including detailed start up schedule and plan for verifying tool process performance.o All systems in mass production and factory start up was successful.• Lead area engineer during site lean transformation to integrated Toyota parts supplier.• Lead the area lean OEE team for full factory OEE evaluation. Attended week long OEE intensive training, performed OEE model generation and data review. • Chemical resistant seals champion. Negotiated evaluation agreement and coordinated the inter-departmental team to test and determine best suppler for our applications. Solution was adopted corporate wide. • Initiated Predictive Failure scheduled maintenance for all dry vacuum pumps Initiated and managed data collection programs for over 300 systems in our factory. Using the data collected, determined standard operating conditions and set parameter based PM criteria that reduced operating costs by over $2 million per year.• Initiated and managed multi-department inventory reduction project saving over $500K in five months. Project included usage projections, cost benefit analysis and future production usage considerations. • Project Manager for next generation high-density plasma CVD system installation. Led scope definition, scheduling of vendor sales team, electrical contractors, plumbing contractors, gas piping contractors, general construction contactors, vendor technicians, and vendor process engineers. Defined and organized 24/7 start-up scheduling,