Manufacturing Engineer Manager

ANA MARIE AISHA E. SACRO

*** *. **** ****** **** Beach, CA 90807 *.********@*****.***

Mobile: 562-***-****

Proven Leadership Track Record

Process Excellence Champion

Training and Methodical Results Oriented Goal Driven Team Player Project Management Expertise

Key Results

Headed Interdepartmental Projects in Custom Media Process streamlining

Ability to manage multiple projects with dynamic shifting priorities and targets.

Spearhead MRP II Project – Capacity Planning Team

Lead Continuous Improvement Initiatives to achieve Operational Excellence

Reduced Cycle time from Raw Material pulling to Shipping from 27 to 15 days.

Assembled new line to support increased demand in Syrup, Production increased by 100%

Increased production efficiency to 25% in 12 months

Reduction of Operations Deviations thru implementing effective CAPA’s

Improved inventory levels from 85% to 98% in 18 months Employment Experience

IRVINE SCIENTIFIC, Irvine, CA

Manager, Manufacturing Engineer 08/2017 – Present

Ensures the effective use of materials, equipment and personnel in producing quality products at minimum costs

Management liaison between Manufacturing, R&D, Quality/Reg and Sales & Marketing for tech transfer process

Develops systems to maintain reports and record keeping of company products

Selects, develops and evaluates engineering personnel to ensure execution of this function

Recommends the improvement of procedures or processes that will achieve better efficiency, cost reduction, and or improved product quality

Assist Manufacturing processes of production issues research of customer complaints

Sr. Manufacturing Engineer 04/2014 – 08/2017

Responsible for creating timelines, allocate budget and make sure that the project is finished within the given time and budget

Lead the Technology Transfer/Custom Process of Industrial Cell Culture Media, Cell Therapy (integration of process, development, technologies, scale up processes, transfer methodology)

Participate in cross-functional teams (Supply Chain, Sales, Marketing, QA, R&D Manufacturing, Finance)

Assess Manufacturing requirements and capabilities prior to transfer of new processes into the manufacturing facilities

Provide process transfer support including generation of process descriptions and facility fit comparisons

Provide tech support and training of manufacturing personnel to improve understanding

Lead, Plan and implement projects (Marketing, QC, QA, Mfg, Ops, Facilities), ensure project status, issues and successes are communicated to project teams

Perform risk assessments and cost evaluation and benefits

Making recommendations for the improvement of any procedures or processes that will result in better efficiency, cost reduction and/or improved product quality using QbD and Six Sigma Techniques

Researching and recommending new equipment and/or manufacturing processes

Utilizing design control procedures for implementation of projects and processes or improvements to product or processes. Preparing and approving protocols and reports related to design control activities.

Writes and executes FAT/SAT, IOQ, PQ, PV, CV Validations and other related engineering studies

Proposing, writing, and reviewing departmental standard operating procedures (SOP’s), deviations and proposal and execution of Manufacturing and Facilities CAPA

Assisting with production floor issues related to the manufacturing process, including research into customer complaints.

Facilitate Tech Transfer from R&D to commercial batch manufacturing

Evaluate and source new manufacturing equipment required for capacity or process improvement. PHARMAVITE, San Fernando, CA 02/2014 – 04/2014

Quality by Design Leader

Plan and evaluate Design of Experiments (DOEs) in the frame of Pharmavite's Quality by Design strategy and to: a) support teams in optimizing formulations and processes and in developing product and process specifications b) support technology transfer group with process optimization during scale-up c) support operations in identification and resolution of commercial production issues.

Apply Design of Six Sigma (DFSS) methodology to implement and support Quality by Design (QbD) program strategies.

Ensure Process Development Design Space (through understanding of QbD and DOE) is aligned with commercial process and equipment capabilities.

Ensure critical process parameters and process control strategies can be implemented in a practical and compliant way in the manufacturing environment.

Ensure that development data are leveraged in justifying process and equipment validation plans and product specifications.

Apply statistical analysis of process validation or technology transfer data for demonstrating validity and suitability. Trending analysis in the frame of continuous process verification and monitoring is required.

Support the introduction of Process analytical Technology (PAT) by facilitating and enabling multivariate process monitoring and control principles.

Provide technical guidance and facility problem-solving methodologies regarding quality-related issues. Ana Marie Aisha E. Sacro 562-***-****

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STANDARD HOMEOPATHIC, Los Angeles, CA 05/2008 – 12/2013

Operations/Process Manager

Current initiatives being reviewed and revised or implemented, include: 5S, Common Tools and Processes review and implementation across the Supply Chain, Packaging Specifications development and revision and Specification Maintenance Review of Form, Fit, Function across packaging line, Conduct Team Building Exercises, review of quality to insure compliance with FDA and GMP.

Review, design, revise, and implemented filler packaging line, which resulted to cycle time reduction from 11 days to 1 day.

(Project timeframe: 1 Month). Packaging efficiencies increased by 35%

Manages and coordinates packaging, specialty and liquid filling department and its operational strategies and activities under the guidance of the VP of Manufacturing.

Liaising with the Director of Supply Chain on planning and predicting customer orders to satisfy shipments for all finished goods.

Review production schedules, engineering specifications, orders, and related information to obtain knowledge of manufacturing methods, procedures, and activities.

Formulate sampling procedures and designs and develop forms and instructions for recording, evaluating, and reporting quality and reliability data. Close interface with Quality department to determine optimal sampling methods and quality systems.

Direct workers engaged in product measurement, inspection, and testing activities to ensure quality control and reliability.

Regulate and alter workflow schedules according to established manufacturing sequences and lead times to expedite production operations.

Prepares Plant Metrics (Deviation, Safety, Training, Customer Service Level)

Confer with vendors, staff, and management personnel regarding purchases, procedures, product specifications, manufacturing capabilities, and project status.

Plan and establish sequence of operations to manufacture products and to promote efficient utilization.

Establish programs of work measurement in order to guarantee fulfillment of targets and deadlines.

Promotes Sig Sigma techniques by continuously developing work processes and tactical strategies to reduce cost and eliminate wastes.

Conducts Manufacturing investigations and periodically reviews Out of Specification trends and performs statistical analyses and provide CAPA to reduce and or eliminate recurring issues.

Confers with management, validation and facilities and engineering, and other staff regarding manufacturing capabilities and capacities, production schedules, and other considerations to facilitate production processes. LEINER HEALTH PRODUCTS, Carson, CA 10/2005-01/2008

Sr. Operations Analyst

Publishes monthly variance and analysis package for production and other supporting cost centers Responsible for timely development of cost estimates for new and derivative products.

Develops, maintains and reports daily shop floor performance metrics to assist management in making strategic and tactical adjustments to enhance efficiency and productivity

Maintains Routers and Bill of Material in the computerized shop floor and cost system as required to reflect true production and product costs

Designs coordinates and prepares special Operations variance analysis and special projects as required by Management

Assist in the Scrap reduction project by introducing KAIZEN techniques

Apply statistical methods and perform mathematical calculations to determine manufacturing processes, staff requirements, and production standards.

SOUTHWIRE COMPANY, Long Beach, CA 01/2005 – 10/2005

Industrial Engineer II

Design, develop, and implement new processes on new products, to ensure timely completion of prototypes and associated costing and manufacturing procedures.

Responsible for timely development of cost estimates for new and derivative products.

Maintains BOM database, recommend changes to adapt to new products and incorporate upon approval.

Provides classical Industrial Engineering support for the implementation of Lean Manufacturing

Develops labor standards, B.O.M. standards, performance factors and performance measurement and reporting.

Responsible for the application of industrial/manufacturing engineering techniques such as methods improvement, process improvement, layout analysis and planning, standard cost development/analysis, engineering economy, statistics, SQC, time study, production planning/machine balancing, simulation, etc. to improve productivity and reduce manufacturing costs. Lean manufacturing principles used whenever applicable.

Responsible for the application of industrial engineering and lean manufacturing techniques to analyze, develop, support and improve production and information systems to reduce costs and increase productivity.

Formulates and provides budgetary information to operations and management

Develop manufacturing methods, labor utilization standards, and cost analysis systems to promote efficient staff and facility utilization.

WATSON PHARMACEUTICALS, Corona, CA 12/2002 – 01/2005 Manufacturing Engineer Coordinator

Participates in the data collection and writing of manufacturing and packaging investigation. Tracks the progress of writing and approval of all investigations. Ensures that the Corrective and Preventative Action (CAPA’s) contained in the deviation investigations are complete.

Close interface with supporting groups (Quality Engineering, QA, QC, Pharmaceutical technology) for project improvement.

Writes all customer complaints investigations assigned to Manufacturing and Packaging departments. Ensures that investigations are thorough and that CAPA’s are completed in the deviation investigations are complete.

Responsible for handling product complaints by investigation and coordinating disposition with Quality Engineering. Ana Marie Aisha E. Sacro 562-***-****

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Spearheads Manufacturing/Packaging projects related to process improvement and Value stream mapping techniques.

Prepares Corona site scorecard (%deviation, safety index, fill rate, performance plan etc.)

Tracks deviation trends and recommends improvements for reduction /elimination of complaints/deviations.

Assists in the development, scheduling, execution and tracking of training activities within the Manufacturing department. Types of training include technical, safety, cGMP and SOP.

Provides information and support during coordination of multi -departmental projects. Includes gathering historical data from batch records and change control archives, performing statistical analysis (using SAS JMP Software) and writing reports.

Team Lead for MRPII - Implements machine and labor tracking and process enhancements projects.

Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product.

Recommend methods for improving utilization of personnel, material, and utilities. PURETEK CORPORATION, San Fernando, CA 8/1999 – 11/2002

Quality Assurance Supervisor

Ensured quality of production work through close supervision of QA Inspectors.

Conduct QA compliance audits of products and processes.

Enforced Good Manufacturing Practices (GMP) compliance and Standard Operating Procedures (SOP).

Assured efficiency of the QC/QA department through cycle time analysis.

Completed value added projects such as benchmarking and improvement techniques.

Coordinate quality control objectives and activities to resolve production problems, maximize product reliability, and minimize cost.

Review product and process non-conformance and recommend remedial actions including but not limited to modifications of processes, products or QA standards where warranted.

Ensure that all QA department personnel are trained to perform their jobs effectively and manage the QA departmental budget and other administrative functions to insure an efficient operation that is cost effective and well integrated. BALTIMORE CONSTRUCTION, Los Angeles, CA 3/1999 – 8/1999

Quality Surveyor, Planner, Estimator

Performed quantitative surveys and take-off of architectural and structural plans.

Performed cost estimations of material and labor for buildings and other construction.

Expertise in utilization of various software tools for scheduling and cost estimating. Education and Professional Development

MAPÙA INSTITUTE OF TECHNOLOGY, Manila, Philippines BS, Industrial Engineering, 1996

Six Sigma Green Belt (USC School of Engineering)

OTHER SEMINARS AND WORKSHOPS

cGMP Training

IIE Member

Management of ISO and Operations Planning

MRPII

RCA Seminars

Technical Writing (Investigation/CAPA)Training

ISPE (International Society of Pharmaceutical Engineers) Member Statistical Process Analysis Using JMP SAS Software

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