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Engineer Project

Pompano Beach, Florida, 33069, United States
May 28, 2010

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Process and Equipment Engineer

Dedicated and hard worker individual with more than 20 years of experience in Chemical and Mechanical Engineering applications for the Pharmaceutical industry to bring significant value to a pharmaceutical or biotechnology company because its extensive design, manufacturing and project management experience.

Process experience includes Process Design and Equipment Engineering, Production Supervision and Management, Validation and Commissioning, and technology transfer to Puerto Rico.

Project management experience includes projects in Bulk Chemical Plant, Pharmaceutical and Chemical and Biological Labs.

Areas of Expertise ───────────────────────────────────────

• Liquid Dosage Formulation • Clean Utilities

• Solid Dosage Formulation • Containment

• Sterilization, Filling and Packaging • Granulation, Drying and Milling

• Bulk Manufacturing and Design • Maintenance

• Validation and Commissioning • Hygienic Systems

• Equipment Specification & Procurement • CIP Systems

Technical Proficiencies ────────────────────────────────────

Industries: Pharmaceutical, Engineering Design and RD

Regulations: cGMP, FDA, NEC, NFPA, European Regulations

Computer Skills: Microsoft Office, Lotus Notes,

PLC Skills: Allen Bradley

Comp. Languages: Basic, Fortran

Engineering Tools: MathCAD, Pipe-flo

Languages: Spanish, English

Education & Credentials ────────────────────────────────────

Bachelor of Science in Chemical Engineering

University of Puerto Rico, Mayaguez Campus, PR

1977 – 1981, Cum Laude

Bachelor of Science in Mechanical Engineering

University of Puerto Rico, Mayaguez Campus, PR

1981 – 1982, Magna Cum Laude

Professional Experience ────────────────────────────────────

Jacobs Engineering, PSC, Guaynabo, PR 2006 – Present

Senior Process Mechanical Engineer

Assist Engineering Manager in the generation of proposals for Pharmaceutical and Biotechnology companies including Scope of Work, Deliverables, Assumptions and Clarifications, Man-hours and Schedule. Develop Process Engineering and Equipment Purchasing Documentation for Pharmaceutical / Biotech Projects. Perform Manufacturing and Process Studies as required by Pharmaceutical / Biotech companies.

Key Achievements:

Amgen, Boulder, Co

• Developed Datasheets and Specifications for agitators, PAT systems

• Corrected and Outdated the Vendor Requirement Documentation SOP.

• Performed a Process Safety Evaluation of the Urea and Sugar delumping processes

Con Agra, Indianapolis, IN

• Provide support to CIP System Upgrade Project.

• Provide support to the RediWhip Reject System Project

• Performed a plantwide Engineering Project aimed to identify Safety Problems

Pfizer Varenicline Project, Barceloneta, PR

• Developed Datasheets and Specifications for Vacuum Transfer System (VTS) for discharging solid material in a Reactor containing Flammable Materials.

• Developed datasheet and specification for the installation of a manhole with dual port for the installation of above VTS.

ASME BPE Code Project, USA, PR

• Gave support to this task force in several areas including but not limited to drawings, PAT systems, L/D issues, etc.

• Participate of the 2009 BPE Meeting held in PR substituting one of the key members of the committee.

Wyeth Fast Acting Project, Guayama, PR

• Developed Specifications for several equipments including a complete sanitary conveyor system, a CIP System, a Sieve / Pnuematic Conveying System, several Drum Manipulators.

• Conducted and study

• Reviewed P&IDs.

Eli Lilly, Guayama, PR

• Performed Pressure Relief Calculations for several storage vessels.

Pfizer Project, Barceloneta, PR

• Developed a documented study of the handling of hoses in a recently installed Filter Dryer in order to facilitate their handling and avoid safety problems.

• Conducted a Hazard Operational Study (HAZOP) for this area resulting in about 15 recommendations including 3 mayor ones, resulting in additional changes to the area in order to bring this operation under compliance.

• Analyzed a dual filter operation for compliance with ASME Code Regulations.

Amgen Project, Juncos, PR

• Developed Datasheets and Specifications for an Electric Clean Steam and two Heat Exchangers

• Develop a Pipe-Flo model for the addition of two heat exchangers in a WFI System

Pfizer Varenicline Project, Barceloneta, PR

• Developed Datasheets and Specifications for Depth Filter, Process Filters, Bag Filters, Reactor Deflector Plates, Diaphragm Pumps, Metering Pumps, Small Addition Vessels, Sampling Valves, PAT systems and Specialty Items.

• Reviewed P&IDs

Abbott ABL Expansion Project, Barceloneta, PR

• Developed P&IDs for Water Pre-Treatment, Purified Water (PW), Water for Injection (WFI) and Clean Steam.

• Developed Datasheets and Specifications for PW and WFI Pumps and sterile filters.

Wyeth Fast Acting Project, Guayama, PR

• Develop a Pipe-Flo model for the two DI Water Systems, Prepared a list of recommendations for the modification of both systems

• Developed Specifications for the Pneumatic Conveying System.

• Conducted a study for the implementation of Super Sacks.

• Developed and Reviewed P&IDs.

Novartis Project, Holy Springs, North Carolina

• Develop Specifications for the Clean Steam System

• Developed Specifications and Bid Packages for the Virus Inactivation Skid.

• Develop Specifications for FRP and Plastics Tanks

Eli Lilly Duloxetine Project, Guayama, Puerto Rico

• Performed Pressure Relief Calculations for storage vessels and reactors.

• Performed Calculations for Solvent Storage Tanks Pumps.

• Performed Calculations for RO Water Distribution Loop.

Amgen ATI Bulk Project, Carrigtohill, County Cork, Ireland

• Developed Datasheets and Bid Packages for Clean Steam Generators, IBC Washers and Dryers, Part Washer and Dryers, CIP Skids and Autoclaves.

• Assisted in the generation of Clean Utilities P&IDs.

Wyeth Product Development Center, Newbridge, Kildare County, Ireland

• Developed User Requirement Specifications and Purchasing Specifications for Tablet Press, Roller Compactor and Contained Waste System.

• Prepared Tablet Press, Roller Compactor and Contained Waste System P&IDs.

• Assisted in the preparation of the Containment and Process Analytical Technology (PAT) philosophy and the Equipment Mobility Study.

Flour, San Juan, PR 2001 – 2006

Senior Process Engineer

Assist Engineering Manager in the generation of proposals for Pharmaceutical and Biotechnology companies including Scope of Work, Deliverables, Assumptions and Clarifications, Man-hours and Schedule. Develop Process Engineering and Equipment Purchasing Documentation for Pharmaceutical / Biotech Projects. Duties included Project Management of several projects.

Key Achievements:

Astra Zeneca (IPR), Canóvanas, PR

• Process and Equipment Lead on the successful conceptual, preliminary and detailed design and procurement of a Solid Dosage facility. Responsible for the equipment specifications, datasheets of high shear mixer, dry and wet mills, post hoist, vacuum system, etc. Also responsible for developing the P&IDs, Equipment General Arrangements, Elevations and operational and cleaning schemes. Worked extensively with equipment vendors to assure that client-specified equipment and engineering firm-specified equipment matched.

Glaxo SmithKline, Cidra. PR

• Process Engineer responsible for the successful design, specification and bid analysis of the Solution Preparation Area tanks, agitators, CIP Skid, drum lifters, heat transfer packages, peristaltic pumps and filters. Responsibilities also included the preparation of the solvent preparation area P&IDS, Equipment General Arrangements and Elevations.

Bristol-Myers Squibb, Barceloneta, PR

• Responsible for data gathering and plant walk-through aimed at updating the Bulk Chemical Plant P&IDs. Participated extensively in the Process Hazard Review of the updated P&IDs. Made about 120 Safety Observations during the Process Hazard Review.

INYX, Manatí, PR

• Process and Equipment Engineering Lead on the conceptual design of an aerosol drug delivery plant. Developed the Equipment List and Basis for Equipment Cost Estimate. This included developing packaging area layouts and code review of fuel and chemical storage facilities also.

Cardinal Health, Humacao, PR

• Process Engineer responsible for technology transfer from the UK to Puerto Rico for a fill/finish facility. This included process design and equipment support for a syringe aseptic filling line.

Pfizer, Manati, PR.

• Equipment Engineering Lead on a large solid dosage project. Develop specifications, datasheets and bid analysis for State-of-the-Art IBC, Dry Mills, Super Sack Unloading System, Environmental Controlled Chamber. Post Hoist, IBC Discharge System, Responsibilities included assisting in the development of Process P&IDs.

AMO, Rio Grande, PR

• Process and Equipment Engineering Lead on the conceptual design of an ophthalmic solutions preparation plant. Developed Process Flow Diagrams, facility cost estimate for Formulation and Packaging Equipment and prepared preliminary Packaging Equipment Layouts.

AMGEN, Juncos, PR

• Project Engineer on the QC Lab Building project. Responsible for the management of the Conceptual, Preliminary and Detailed Design of the lab. Developed

Alcon / Cardinal, Humacao, PR 1998 – 2000

Formulation & Packaging Supervisor

Responsible for the production and packaging of tablets and aseptic liquids. Responsible for the performance of 23 operators, 2 group leaders and 1 documentation clerk.

Key Achievements:

• Maintained production activities at 98% adherence vs. schedule.

• No lost of bulk material or packaging lots.

• Updated and improved all production documentation (Standard Operating Procedures, Master Batch Records (MBR), etc.

• Submitted eight process improvement projects aimed to increase productivity, product safety and morale and to reduce operational cost.

Alcon / Cardinal, Humacao, PR 1993 – 1998

Process Engineer and CAD Coordinator

Responsible for the design, project management, maintenance and troubleshooting of all aseptic ophthalmic formulations and filling. Responsible for several mechanics performance. Responsible for the CAD department and two CAD Operators.

Key Achievements:

• Designed, specified and installed updated liquid formulation process areas. Converted existing facilities from ’70 technology to state-of-the-art technology.

• Established proven PM procedures for all process area equipment.

• Designed, procured, installed and maintained the only media failure-free production area of the entire corporation. This design serve as the design example for many other systems developed later by the corporation.

• Developed first CAD system procedure for Engineering.

• Supported plant wide project CAD requirements.

CIP Plants, Inc., San Juan, PR 1991 – 1993

Process Design Engineer, San Juan, Puerto Rico.

Responsible for developing process flow diagrams, P&IDs PLC scenarios and instrumentation sheets. Developed and executed environmental and process-related studies and assisted the Electrical / Instrumentation Department in the design of hardwire and PLC-driven control systems and instrumentation.

Bristol-Myers Squibb, Humacao, Puerto Rico. 1989 – 1991

Production Facilities Manager

Responsible for the operational, financial and safety aspects of a Bulk Production Facility aimed for the production of Nadolol and its intermediaries. Responsible for the supervision and performance of 4 supervisors, 1 secretary, 23 operators and 1 documentation clear.

Key Achievements:

• Implemented solvent reclamation processes that reduced solvent consumption by 70%. Won award for this effort.

• Improved financial status of the manufacturing designing from a negative variance of $400K to a positive variance of $600,000 per year.

• Implemented process operations aimed to improve the yield of one of the intermediaries by 25% which resulted in an improvement of about 10% on final product yield.

• Implemented cleaning procedures aimed to ease and accelerate changes from one campaign to another.

• Implementing 10 environmental and safety projects aimed at reducing workers’ exposition to hazardous materials and improve moral. These included scrubbers, solution transfers, keeping vessels closed at all times.

• Implemented a GMP audit to monitor operations performance during normal operations and during unscheduled visitors.

• Won award for most GMP and Safety compliance facility.

• Implemented personnel changes which resulted in the reduction of documentation incidents and improved personnel moral.

Bristol-Myers Squibb, Humacao, PR 1988 – 1989

Project Manager

Responsible for the design, implementation, financial and safety aspects of a several plant wide projects

Key Achievements:

• Implemented a plant wide computer network aimed to streamline warehouses and production facilities reporting and asset utilization.

• Implemented a Methylene Chloride reclamation project which reduced by $1M its usage.

• Implemented a project aimed to eliminate the lost of an autoclave load after loss of power or steam capacity.

NASA Lewis Research Center, Cleveland, OH 1982 – 1988

Aerospace Materials Engineer

Responsible for developing manufacturing and testing equipment for metal matrix composites space materials. Marketed research projects for NASA to obtain funding from other government agencies.

Key Achievements:

• Co-authored three research papers on metal composites and super alloys.

• Earned four Merit Awards for research excellence.

• Served as liaison between materials and structural departments in several Space Shuttle Projects aimed to improved combustor performance.

• Prepare specifications and procurement documents for processing equipment including a material testing lab.

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