OBJECTIVE:

Obtain a challenging position in Project Management, Production plant manufacturing Operations, Product development and Process Engineering fields.

SUMMARY:

• Capital Project Management Professional with a full depth and breath of knowledge regarding Product Proof of Conception/feasibility studies, Project Proposals, Review of Basic and Detailed Engineering concepts, Design evaluations, Budgeting, Risk assessments, KPI’s, Procurement, Planning and Construction.
• Highly experienced professional in Confidential Manufacturing, New Product Introduction of Hematology Instruments, Reagents manufacturing, Formulation, Filling equipments - high speed rotary equipments for small to large size cubitainers, variety of bottles, vials. Labeling, Packaging, implement Vision system etc.
• Expertise in new plant start-up & commissioning of fully automatic continuous process plants, Manufacturing Operations, Troubleshooting, Solve complex production issues, Quality control, FDA Remediation Projects, Technical services, Safety and Equipment Maintenance. winner at Confidential .
• New Process Development using variety of technologies e.g. Hollow Fiber, Continuous centrifugation & design wall mounted filtration system.
• Process & Design Engineering of Production tanks, transfer piping, write User Requirements, Functional Specification, Design Specification
• Develop drawings, P&ID and PFDs.
• Process and Equipment Validation- Write Validation (IQ/OQ/PQ) protocols
• Perform validation execution and write final reports. Installations of new DI Water loop and perform the system Validation.
• Subject Matter Expert for SAP, ERP Implementation.
• Environmental Project, Risk Assessments - PFMEA and DFMEA, Hazop study, Process Safety Management (PSM).
• Quality Engineering - Corrective and Preventative Action (CAPA) - Participates in development of Corrective and preventative action plans.
• Expertise in Design control, Change control, Quality Assurance and customer Complaint investigation and propose solution.
• Polymer processing using extrusion, injection and blow molding machines.
• Write and update Standard Operation Procedures (SOPs) and Work Instructions.
• Provide for Production Team Members.
• MS Project, Pro-chain, Leader (Hazop), AutoCAD, Mechanical Desktop, Intellution & Lookout software for computer based process control, Visionscape software RVSI Acuity CiMatrix, AutoCAD2000i, Mechanical desktop, Inventor and Autocadlite software.

PROFESSONAL EXPERIENCE:

Confidential, Plano, TX

PROCESS ENGINEERING SPECIALIST

Responsibilities:

• Perform Line Transfer; Feasibility and Characterization Build for New HOX Machine.
• Process Development, Write Work Instructions for Manufacturing the X-Ray machine.
• Perform Confidential (Risk Assessment) for Manufacturing Process and Equipments.
• Write IQ, OQ and PQ Protocols, execution of Validation protocols and write final reports.
• Develop processes & validate processes in order to get the equipment running and then to qualify it.

Confidential, Fremont, CA

EQUIPMENT VALIDATION SPECIALIST

Responsibilities:

• Validation of the Package Erector Equipment (automated packaging equipment), labeling equipment.
• Perform Site Acceptance Testing (SAT) for new equipment.
• Develop processes & validate processes in order to get the equipment running and then to qualify it.
• Write IQ, OQ and PQ Protocols, execution of Validation protocols and write final reports.

Confidential, Thousand Oaks, CA

MANUFACTURING SPECIALIST

Responsibilities:

• Process Owner to provide broad operational support to the manufacturing floor.
• Drive continuous improvement in the plant and tracks progress on a plant level.
• Owns and maintains the manufacturing production schedule.
• Coordination with New Product Introduction leads, Supply Chain and Planning, Facilities and
• Engineering as well as Manufacturing to ensure the production schedule is accurate and up to date.
• Support Manufacturing in troubleshooting Non - Conformance events, conducting problem solving and RCAs, owning class 2/3 NCs, and works with Quality, F&E, EH&S, PD, CPE etc. to develop and own CAPAs to prevent recurrence.
• Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings.
• Provide Technical expertise, lead projects to introduce new products and/or advanced technologies into the plant.

Confidential, Newark, CA

LEAD OPS/QUALITY & NPI PROJECT MANAGER

Responsibilities:

• Manage Manufacturing operations and Quality Engineering staff for Illumina's New Product Introduction NeoPrep system used for DNA Testing.
• Lead project management efforts for New Product Introduction and New Product Development
• Create, optimize, and streamlined structured production schedules and project plans.
• Improved and streamlined inventory controls for required components for production.
• Started daily production staff meetings to review progress of manufacturing and planning and implemented daily production reporting system for operations in Malaysia.
• Reviewed quality issues and shortage of raw material used for production.
• Perform validation of NeoPrep System.
• Perform Engineering studies, DOE, collect data, data analysis and prepare reports etc.
• Review and update Standard Operating Procedures.
• Purchasing, Receiving and Inventory control management.
• Resolve quality issues of components with various vendors and customer.

Confidential, CA

SR. QUALITY SPECIALIST

Responsibilities:

• Working on Magma remediation plan- identify, review design critical components on Confidential analysis.
• Resolve manufacturing issues of Confidential .
• Work with Vendors and Contract Manufacturer to get of analysis or of conformity; on identified critical components.
• Prepare Material specifications for Critical components.

Confidential, NY.

VALIDATION & QUALITY SPECIALIST

Responsibilities:

• Perform gap analysis and provide recommendation for validation.
• Write validation (IQ/OQ/PQ) of Baxter Sigma Spectrum Infusion pump and components.
• Perform Engineering studies, DOE, collect data, data analysis and prepare reports etc.
• Review Validation failure reports and resolve issues.
• Review and update Standard Operating Procedures (SOPs).

Confidential, Hercules, CA

SR. MANUFACTURING PROCESS ENGINEER/PROJECT MANAGER

Responsibilities:

• Support Manufacturing Operations of Reagents manufacturing, Reagent formulation, Reagent filling and Reagent packaging - Large and small bottles, Vials, Cubitainers, Vision system, Labeling etc.
• Subject matter Expert (SME) for implementation of ERP SAP MDM Project for all Bio-Rad Worldwide operations.
• Process Engineering & Project Management - Implement Capital Projects from start to finish.
• Start up, de-commissioning of filling machine and Lyophilizers equipment.
• Experience in design specification and operations of CIP, COP, Autoclaves and Lyophilizers equipment.
• Develop design specifications, detailed engineering, and execution & validation.
• Perform Engineering studies for process and equipment including DOE, analyze blood samples on various instruments, collect data, data analysis and prepare reports etc.
• Review and update SOPs, etc. Perform validation (IQ/OQ/PQ) of system equipment and manufacturing processes.
• Performed various Processes and Equipment improvement and Cost reduction projects.
• Perform CAPA investigation and Quality Assurance and customer complaint investigation and propose solution.

Confidential, Alameda, CA

STAFF MANUFACTURING ENGINEER/PROJECT MANAGER

Responsibilities:

• Support Manufacturing Operations of Reagents manufacturing, Reagent formulation, Reagent filling and Reagent packaging - Large and small bottles, Vials, Cubitainers, Labeling etc Manufacturing Operations of Reagents manufacturing, Reagent filling and packaging.
• Perform validation (IQ/OQ/PQ) of system equipment and manufacturing processes.
• Perform Process Improvements and Cost reduction.
• Support Manufacturing Operations of Reagents for Genetic Testing.
• Perform calibration of equipment and instruments used for manufacturing.