Industrial/Manufacturing Engineer

OBJECTIVE

Obtain a position that will enable me to contribute in creative ways to increase the company’s productivity using my strong organizational skills, educational background, and ability to work well with people.

EDUCATION

Polytechnic University of Puerto Rico

Master in Manufacturing Engineering

University of Puerto Rico, Mayagüez Campus

BS. Industrial Engineering

Licensed Engineer (Lic. No. 22722, EIT)

SUMMARY OF QUALIFICATIONS

Licensed Engineer with over 6 years of professional experience in quality assurance, quality control, manufacturing, packaging, equipment validation and packaging supervision in the pharmaceutical industries.

 Broad experience in pharmaceutical manufacturing, and packaging lines operations.

 Supervisory experience with operators and mechanics in the packaging area.

 Knowledge of CGMP, FDA regulations, OSHA, TQM, Lean Manufacturing, and Six Sigma.

 Experience handling quality related events and performing thorough investigations.

 Experience with Cleaning Validation Protocols and Technical Reports.

 Experience with sterilization and depyrogenation Performance Qualification Protocols.

 Experience with the generation of Computer Validation Life Cycle Documents.

 Experience with Notice of Events (NOE) and Corrective Action Preventive Action (CAPA) documents.

 Supervisory and management skills.

 Exceptional leadership, skilled in motivating and managing teams to achieve desired results and company goals.

 People and teamwork oriented with the ability to work under pressure and with minimum supervision.

 Organized person with excellent communication and interpersonal skills.

 Excellent documentation and presentation skills.

 Self-starter with the ability to adapt to changes quickly and handle multiple priorities.

 Computer literate with experience in several computer software.

 Fully Bilingual (Spanish and English).

WORK EXPERIENCE

International Scientific-A, Inc. April 2006 to Present

Perform different assignments as a Consultant within the pharmaceutical industry:

Biovail Laboratories International, SRL, Dorado Facility

Packaging Supervisor

 Supervise, schedule and coordinate daily activities in the packaging of products in compliance with current Good Manufacturing Practices.

 Conduct investigations for the situations encountered and documented in the Notice of Events documents.

 Assist in the development and planning of all long term packaging strategies and schedules to ensure the timely and efficient operation of the packaging department.

 Developed packaging procedures and ensure the implementation and compliance with production requirements.

 Assist with troubleshooting daily operational/technical scheduling issues to accomplish short and long term packaging objectives.

 Complete packaging projects assigned as per agreed schedules.

Technical Engineer

 Management and Supervision of the qualification projects following and applying the pharmaceutical policies.

 Review/ Approve Qualification protocols, gathering and reviewing data to compare it against protocols acceptance criteria.

 Provide support to the Technology Transfer, Quality Control, Quality Assurance and Engineering and Maintenance Departments.

 Perform tasks as of project management requirements.

 Developed Standard Operating Procedures.

 Conduct assessments for the Corrective Actions Preventive Action (CAPA) investigations.

 Trainings to the Quality Control, Manufacturing, Packaging and Engineering and Maintenance personnel.

 Write Validation Plans, User Requirements Specifications, Functional Requirements Specifications, System Design Specifications, Installation and Operational Protocol for the Systech Vision System.

 Write/review/execute Installation and Operational Protocols for the manufacturing and packaging equipments such as Lightnin Mixer, NIRO MP 4/5 Fluid Bed Dryer, API Shrink Bundler, Merrill Filler Machine, Enercon Induction Sealer, Capper Machine, Unscrambler Bottle Inverter, Stability Chambers, and Sanyo Pharmaceutical Refrigerators.

 Prepare Qualification Protocol Final Reports.

 Write/review/execute Installation, Operational and Performance Qualification Protocols and Summary Report for the Compressed Air Distribution System.

 Write/review/execute Installation and Operational Protocols for the Control System of equipment such as the Aeromatic CU-4 Fluid Bed Dryer.

ECHO Consulting Group November 2005 to April 2006

Validation Specialist

Prepared documentation and executed validation projects in Biotechnology Industry.

Amgen Manufacturing Limited, Juncos Facility

 Development and execution of Cleaning Validation Protocols for CIP solution tanks and transfer lines.

 Development of Technical Reports for a CIP Project.

 Development and execution of Periodic Monitoring Protocols for steam sanitization and Sterilization in Place protocols for equipments such as Solids Collection Tank / Cell Paste system, Production Fermentor, Centrifuge Recovery System, and Oxidation Tank.

 Train the Microbiological Laboratory and Manufacturing areas personnel..

Pharmaceutical Validation Solutions Corp. July 2003 to September 2005

Validation Engineer

Prepared documentation and executed validation projects in Pharmaceuticals Industries.

Biovail Laboratories International, SRL, Dorado and Carolina Facilities

 Developed Computer Validation Life Cycle Documents for a Manufacturing Equipment. Participate in the coordination of qualification protocols activities execution.

 Development and execution of Installation and Operational Qualification Protocols for the equipments of the manufacturing and packaging areas.

 Development and execution of Facility Qualification Protocols for the Manufacturing Area.

 Development and execution of a Commissioning Protocol for a Thermal Oxidizer.

Schering Plough, Ltd, Manatí Operations

 Development and execution of Performance Qualification Protocols for sterilization and depyrogenation equipments of the Manufacturing Area.

 Conduct an Engineering Study for a Media Fill process.

 Assist in the development of the Summary Report for the HEPA filter certification.

 Plans and schedules validation efforts associated with assigned projects

 Train the Microbiological Laboratory, Manufacturing, Engineering, and Technical Services personnel involved in the qualification activities.

Washington Group International April 2003 to June 2003

Validation Specialist

Prepared documentation and executed qualification projects in Pharmaceuticals Industries.

Merck Sharp & Dohme, Barceloneta Facility

 Execution of Installation Qualification Protocols as part of the Remediation Project.

 Documentation of Protocol Change Notices and Installation Completion Records.

PROFESSIONAL MEMBERSHIPS

Member of Colegio de Ingenieros y Agrimensores de PR (CIAPR)

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