Engineer Manufacturing

E i l e e n Y. R a m í r e z-C h a p a r r o, PE

**** ******** ******** ****. ***. G-13

Metairie, LA 70003

Ph.: 787-***-**** e-mail: *******.******@*****.***

SUMMARY

Over six (6) years of experience in Industrial Engineering, Manufacturing, Validation and Quality Assurance with the Pharmaceutical and Medical Devices Industries. Highly effective in Statistical Process Control, process & performance capability studies, design of experiments, process validation, manufacturing line optimization, design of work stations, investigations of manufacturing and customer complaints (CAPA’s), and product transfer activities.

PROFESSIONAL EXPERIENCE

Edwards Lifesciences Särl, Añasco, PR Feb 2010 – Nov 2011

Manufacturing Engineer

• Provide technical expertise and validation efforts required as part of the Injection Molding Product Transfer Activities.

• Development of design and requirement specifications for the manufacturing processes of catheters.

• Generation of incoming inspection procedures for the receiving of parts and execution of first article inspections.

• Responsible for the implementation of improvements initiatives focused on costs reduction and process optimization using Lean Manufacturing Technologies, Six Sigma and Total Productive Manufacturing tools. Activities included but are not limited to; execution of process & performance capability studies, design of experiment and Statistical Process Control.

• Perform outside vendor’s audits and qualifications in accordance with the company policies.

• Responsible for the implementation of predictive, preventive and corrective maintenance programs for critical systems/equipment. Activities included execution of failure mode analysis, development of reliability programs and execution of manufacturing CAPA investigations.

URS, San Juan, PR May 2007 – Jan 2010

Validation Specialist

• Provide technical expertise for commissioning and validation efforts required as part of the start-up of an ETO Sterilization Facility at Becton Dickinson in Mexico City. Activities include but were not limited to the preparation and execution of validation deliverables such as Validation Master Plans, Factory Acceptance Test, Functional Requirements and Equipment and Facilities Qualification protocols.

• Generation and modification of Manufacturing Standard Operating Procedures (SOP’s).

• Perform time studies to update the standard time and balance the production lines.

• Lead product, process, and machine transfer activities from Puerto Rico to Dominican Republic and Brazil.

• Support the initial operation as a finished good manufacturing plant at Dominican Republic.

• Perform coordination to install and validate manufacturing equipment.

• Support the transfer and shutdown of a manufacturing medical devices plant.

B|BRAUN MEDICAL INC., Sabana Grande, PR July 2005 - May 2007

Industrial Engineer

Pharmaceutical & Medical Devices Industry

• Provide engineering support to manufacturing activities in compliance with ISO Quality Systems Standards. Activities included but were not limited to; design and modification of plant layouts, execution of time studies and process optimization, execution of manufacturing CAPA and customer complains generation and execution process and machines validation protocols, and design of manufacturing fixtures and tools.

EDUCATION AND CERTIFICATIONS

Bachelor Degree in Industrial Engineer – Professional Engineer

University of Puerto Rico,

Mayagüez Campus

AFFILIATIONS

College of Engineers and Land Surveyors of Puerto Rico (CIAPR)

OTHER SKILLS

• Computer literate, knowledge in application software’s (Word, Excel, PowerPoint, Project).

• Strong knowledge in ISO, cGMP’s and Quality Systems Regulations.

• Strong knowledge in IQ, OQ and Process Validation.

• Knowledge in FMEA and Gap Analysis.

• Bilingual, Spanish & English.

• Technical writer.

• Strong knowledge in Six Sigma, TPM, DOE, Economy, SPC, MRP and Project Management skills.

• Strong knowledge in SAP, Documentum, Trackwise, Pilgrim and JD Edwards

• Proficient with AutoCAD and Solid Works. Strong ability to interpret drawings, schematics and detailed work instructions.

• Basic knowledge of OSHA and EPA regulations

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