SUMMARY:

• Certified Lean Six Sigma Black Belt, Senior Mechanical Engineer/Project Manager/Validation/Calibration/Maintenance Engineer/Reliability Engineer with 19 total years experience in bio/pharmaceuticals, medical devices, nutraceuticals and food regulations.
• Managed CMMS Maximo System. In charged of Preventive, Predictive Maintenance and Calibration programs for Manufacturing Operations, Micro and R&D Labs, Facilities such as HVAC, Utilities, Compressed Air System, Chillers, Boilers, Autoclave, Incubators, Test equipment and Manufacturing Equipment.
• Experienced of the Computerized Quality Management Systems, Products, Processes & Equipment Validation (e.g. FAT, Validation Plans, User & Functional Requirements, Design Specifications, Risk Management Plans, IO/OQ/PO protocols, Traceability Matrices, Deviation Handling & Final Reports)
• Experienced of Project Management including capital projects (e.g. budgets, %ROI and request for capital expenditures RCE) by using risk analysis, statistics and financial justification methods and completing project engineering cycle from Initiating, Planning, Executing, Monitoring & Controlling and Closing.
• Utilized Continuous Improvement Tools such as Six Sigma - DMAIC, Lean Manufacturing, Class A and Validation (e.g. Temperature Mapping, Process Mapping, Fishbone (CI) Diagram, Cause-and-Effect (CI) Matrix, Pareto Chart, SPC, MSA, DOE, FMEA, DFLSS, DFMA, 5S, VSM, TPM, PM and SMED quick changeover) to improve safety, quality and throughput.
• PLM experienced with medical catheter manufacturing process, pharmaceutical packaging, plastic parts design, injection molds/tool/fixture design and Nutraceutical, Nutritional food manufacturing.
• Worked with R&D to provide testing, design, analysis & development to ensure the reliability of release products.
• Experienced with CMMS MAXIMO, Cognos Report, SAP ERP, MiniTab, SolidWorks, Pro/E solid modeling, AutoCAD, Visio and Microsoft Project.
• Maintenance Excellent (MEx) Leader - implemented Reliability Centered Maintenance (RCM) & MEx programs and best practices to improving Safety, Quality and Throughput.
• Certified Lean Six Sigma Black Belt - Confidential Laboratories
• Improved Throughput Line 4 and Line 1 (2% OEE)
• Optimized Preventive Maintenance (Maximized Manufacturing Lines Uptime)
• Implemented Computer Software Real-time Bar Weight Statistical Process Control Line 4 Implementation (saved $85,000 annually)
• Plant Utility Kaizen (Reduced cost avoidance, with multi-million dollar cost potential per occurrence)
• Implemented Plant Metal Extraneous Materials Prevention Program

PROFESSIONAL EXPERIENCE:

Confidential, Thousand Oaks, CA

Engineering Project Manager

Responsibilities:

• Designed & reviewed the start-up Pilot-Plant and Scale-up Clean Room Facilities
• Proposed, reviewed, approved Capital Equipment Purchasing (e.g. RODI Water System, CIP/COP System, Tanks, Centrifuge, Evaporator, Spray Dryer, Boiler)
• Proposed, reviewed, approved and managed Engineering, Mechanical, Electrical and Validation Contractors
• Managed and installed equipment for Pilot Plant. Ensured to meet Confidential Safety Standards, UL & Quality compliant requirements.
• Wrote RFQ, Scope of Work for Engineering and Contractors
• Wrote Equipment Specifications and Procedures
• Created, reviewed and updated Nutraceutical & Winery Equipment, Facilities, SOPs and Processes to exceed Confidential, cGMP and FSMA Compliance Regulations

Confidential, Concord, CA

Verification / Validation Engineer

Responsibilities:

• Reviewed prior legacy test protocols for the Hemodialysis machine from CAPA requirements
• Created and wrote the detailed protocols to test and to verify the design output(s) the meet the stated requirements
• Executed “Dry-run” test protocols
• Summarized the test results and reports

Confidential, Fairfield, CA

Project Manager

Responsibilities:

• Managed $250,000 Oil Free Compressed Air System Capital Project and $500,000 Soy Crisp Delivery System Capital Project to successful implementation including designing, bidding, selecting and writing/executing IO/OQ/PO protocols
• Wrote and executed multiples of de/commissioning, Validation IO/OQ/PO packages for Micro Lab, MFG. Operations, Warehouses & Facilities (e.g. autoclave/incubator/freezer/hot & cold room/chambers/Compressed Air Systems/Boilers/Pumps/Metal Detectors/Checkweighers/automation equipment)
• BEx Lean Six Sigma Black Belt Project Managers and Leaders for Plant Utility Kaizen, Increase Throughput, Optimized Preventive Maintenance and Reduce Late Start Up projects for Manufacturing Lines.
• Set up framework for PM, PdM and calibration process at plant for maintenance groups and contractors providing implementation and system support. Administered and facilitated Preventive Maintenance (PM) and Calibration modules within Maximo & Cognos serving the subject matter expert (SME). As the SME, created plant procedures and ensured that impacted groups (e.g. Facilities, Mfg. Operations, Maintenance, QA, Sanitation, 3rd party vendors/contractors, etc.) were in compliance.
• Performed Asset Management Gap Analysis
• Implemented Maintenance Playbook & Strategies
• Created and setup assets, Maintenance Standard Work, job plans, data sheets for Preventive Maintenance, Predictive Maintenance and Calibration programs.
• Developed Maintenance PM/PdM tasks, spare parts and frequencies based on FMEA
• Developed and tracked KPIs to improve equipment reliability and OEE.
• Shared Maintenance Best Practices across facilities that enhanced manufacturing and maintenance reliability.
• Provided site engineering support to/for maintenance, production, labs & facilities.
• Leaded the Plant shutdowns and scheduled activities
• Wrote/executed capital projects (RCE). Such leads include, but not limited to bid/quotation process, vendor/equipment selection, de/commissioning/ IO, OQ, PQ validation & SOP procedures.
• Identified leads and executed ideas/projects to improve product quality, process (efficiency), Business Excellent BEx and cost savings (CIP) measures.
• Actively participated to ensure that internal and external audit actions items were completed on time as well as performing investigation, identifying root causes and providing appropriate corrective actions. An SME for Confidential and Confidential audits.
• In addition to these responsibilities, was an Interim Maintenance Supervisor to support 7/24 Operations (12 maintenance techs) for 6 months and whenever Maintenance Supervisor was not filled.

Confidential, Sandy, UT

Process Manufacturing Engineer

Responsibilities:

• Technical support, troubleshoot and performed continuous improvement for 7 high speed Autoguard Full Automation lines - zone 1 and 6 Insyte Semi-Auto Machine processes.
• Project leader on new capital medical equipment “Stand-Alone Auto Cut Tubing Equipment” as well as performed product and process FMEA, Design Verification & Design of Experiments.
• Wrote $80,000 Capital Budget recommendations and the Equipment Specification that for equipment to be built for the manufacturing and Confidential regulatory requirements.
• Completed a Six Sigma project within six months that met the quality requirements and increased the Overall Equipment Effectiveness.
• Worked with R&D all phases from trial to release final product to Operations to ensure Manufacturability and in compliances.
• Identified and designed manufacturing processes to improve cost effectiveness and reduced cycle times for both product and equipment through engineering studies, capital projects and Kaizen suggestions.
• Leaded and participated in failure investigations by performing MSA, DOE, FMEA and root cause analysis to have the corrective action and the preventive action in place per customer complaints, and CAPA related issues.
• Updated Quality plan documents, SOP and work standard procedures.
• Wrote and executed Engineering Study protocols, Process IQ/OQ/PQ validation protocols and Software IQ/OQ/PQ validation Protocols.
• Wrote and trained Temporary Deviations and Single Point Lessons to production associates while updating the documents.
• Ensured all activities are in compliance with Quality System and Confidential regulation requirements. Facilitated and anticipated in the Blitz.

Confidential, Lincoln, NE

Pharmaceutical / Bio Technical Support

Responsibilities:

• Technical support, perform set-up, troubleshoot and modified for the line changeovers, electrical / mechanical adjustments, control panels, fillers, cottoners, heat tunnels, cappers, metal detectors, check-weighers, labelers, outserters, case packers, case labelers and time tracking systems.
• Designed to improve tooling, modification, prints, specifications, vended equipments and reduce production cost.
• Provided on-time delivery of products, high product quality, high manufacturing efficiency and supported project implementation successfully.