Industrial Engineer

Vanessa M. Rivera

*** **** *** *** *** Suite * Dorado, Puerto Rico 00646

787-***-**** ************@***.***

Summary of Qualification

Wide experience in manufacturing, project/industrial engineering and quality systems areas within the Medical Device, Biotechnology and Pharmaceutical Industry. Responsible for the quality assurance system used for supplier qualification. Demonstrated strong working relationship with peers, subordinates and management. Extensive supervisory experience of personnel working on incoming inspections and product release, process operators and contractors. Computer literate in Microsoft Office (Word, Excel, Power Point, Access, Project and Visio), vast knowledge in the use of special applications: Trackwise, Pilgrim, Enable, SAP, GETS, Kronos and Internet. Bilingual English and Spanish.

Accomplishments

• Green Belt Certification - successfully implemented Project “Batch Record Simplification”.

• Led training team ISO 14000 - successfully achieved plant certification; trained personnel in basic concepts, terminology and Incoming Lean Design.

• Led team and coordinated the Y2K Event for the site.

Professional Experience

Ortho Biologics LLC, Manatí, Puerto Rico

Manufacturing Process Expert 2006 - 2009

• Responsible for assessments of process situations along with the manufacturing area and provided technical input and performed troubleshooting of the process.

• Responsible for the Special Response Team and leading to resolve events in the manufacturing process that could have an impact in the product.

• Documented process events or escalated to Non Conformances as determined by the Special Response Team.

• Monitored unusual trends related to the manufacturing process and established adequate corrective actions.

• Accountable for the completion of the events and non-conformances of the area, as well as CAPA’s related to documentation or processes.

• Evaluated the effectiveness of corrective actions and recurrence of events.

• Performed and reported metrics related to events and no-conformances of the area, and developed One Pager for trend reports.

Lifescan, LLC, Cabo Rojo, Puerto Rico

Sr. Supplier Product Release Quality Engineer 2005 – 2006

• Accountable for the overall Supplier Quality Assurance System (program maintenance and development), including Quality System indicators integration, analyses, and provided feedback to the plant CAPA System.

• Developed Quality Specifications and Process Control Techniques.

• Responsible for the Quality Review of designated process validations.

• Designed sampling plans and applied statistical techniques to improve process quality performance.

• Identified, recommended and implemented initiatives for continuous process improvements.

• Investigated, recommended and implemented corrective and preventive actions.

• Developed Processes and Supplier Control Plans / Developed and reviewed FMEA’s.

• Worked in the resolution of quality issues with suppliers and process owners.

• Investigated customer complaints related to product, process and raw materials.

• Established and maintained supplier product process quality metrics.

• Led and supported the closure and analysis of product, process and supplier related NC and CAPA’s.

Sr. Supplier Quality Operations Facilitator 2003 – 2005

• Led the development and implementation of Quality Systems to assure process robustness and regulatory compliance.

• Facilitated Incoming Inspections, Calibration Program, Process Auditing and Product Release.

• Served as a consultant in the quality related operations and quality system applicable to the plant products and process.

• Provided guidance and recommendations as needed.

• Ensured all direct personnel were properly trained to perform their adding function in accordance with applicable GOP’s and WI’s.

OMJ Pharmaceuticals Inc., San Germán, Puerto Rico

Quality Engineer 2000 – 2003

• Conducted trend analysis on data from various QA Systems (NCR’s, Customer Complaints, Supplier Quality, etc) to assess the efficacy of the corrective actions and identify significant opportunities for improvement.

• Conducted Pareto Analysis of all quality-related investigations.

• Conducted FMEA’s and developed sampling plans as needed.

• Assisted associates and provided training to improve their understanding and use of statistical tools such as control charts.

• Analyzed planned and unplanned process changes to identify improvements.

• Worked with Technical Experts to develop project proposals.

Staff Industrial/Project Engineer 1999 – 2000

• Developed Project Requests and Capital Appropriation Requests.

• Implemented capital projects providing ergonomic facilities to process areas.

• Conducted ergonomic assessment projects.

Bristol-Myers Squibb, Mayagüez, Puerto Rico

Productivity Officer and Packaging Supervisor 1998 – 1999

• Responsible for the Packaging Operations at the Oncological Parenteral suite.

• Supervised process operators and maintenance support personnel for the manual and automated packaging operations.

• Responsible for process qualification protocol development and execution.

• Responsible for overseeing budget control of departmental expenditure, labor costs and efficiency, and productivity.

Qualification Engineer 1997 – 1998

• Developed and executed qualification protocols (IQ/OQ/PQ).

Project Engineer 1997 – 1997

• Developed Project Requests and Capital Appropriation Requests.

• Implemented capital projects in packaging areas.

Staff Industrial Engineer 1993 – 1996

• Performed time and motion studies to establish manufacturing standards.

• Reduced changeover in process area using SMED techniques and capacity analyses, accountability and reconciliation studies, and economical analyses.

• Led Quality Action Teams to improve quality and productivity.

• Provided SPC (Statistical Process Control) training to process operators.

Oximetrix (Abbott) of Puerto Rico, Inc. (Ponce, Puerto Rico)

Manufacturing and Certification Engineer 1991 — 1993

• Performed process and commodity improvements.

• Executed product transfer, workstation designs, standards estimates, SOP development and personnel training.

• Performed equipment validations of ultrasonic welding and testing machines.

Industrial Engineer 1989 — 1990

• Performed equipment layouts, time and motion studies, workstation design, noise studies, and equipment validation.

• Performed equipment validations using Taguchi and Design of Experiments techniques.

Education

MBA Industrial Management

Interamerican University – San Germán, Puerto Rico

BS Industrial Engineering

University of Puerto Rico – Mayagüez, Campus

Certifications/License

• Medical Device Industry Registered Auditor ISO 13485

• Green Belt (Six Sigma Methodology) / Johnson & Johnson Process Excellence

• Biotechnology Certification (University of Puerto Rico – Arecibo, Campus)

• EIT 23783 License (PR State Dept., Colegio de Ingenieros y Agrimensores de Puerto Rico)

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