Engineer Manager

WILLIAM FUENTES July **** Resume: Page * of *

RO-86 Urb. Riachuelo, Trujillo Alto, P.R. 00976 939-***-**** / 787-***-****

SUMMARY OF KEY COMPETENCIES

• Strong experience and technical expertise of all aspects of parenterals manufacturing processes and

o peration (preparation, formulation, filling, lyophilization, sealing and packaging).

• Successful leadership of complex process equipment and technology projects, from conceptual definition to

commissioning, validation and commercial operation.

• Development of capacity models and strategic plans to support large capital investments.

• Thorough understanding of Statistical Process Control, Quality Auditing, Lean and Six Sigma.

• Computer skills (MS Word, Excel, Powerpoint, MS Project, MS Access, Minitab and others).

• Effective communication, presentation and leadership skills. Fluent in English and Spanish.

• Excellent interpersonal skills and teamwork- oriented personality. Collaboration, integrity and results

focused.

EDUCATION

• BS Mechanical Engineering (University of Puerto Rico, 1986)

• MBA Management (University of Phoenix, 1995)

WORK EXPERIENCE AND ACCOMPLISHMENTS

JANSSEN ORTHO LLC (a Johnson & Johnson Company), Gurabo PR

Process Engineering Manager (August 2003 – Present)

Reporting to the Parenterals Project Director. Lead the Process Engineering & Maintenance organization to achieve a

successful design, construction, commissioning and startup of a new sterile pharmaceutical facility.

• Led design, procurement, startup and commissioning of direct impact process equipment for the formulation,

components prep, aseptic filling, lyophilization and capping areas.

• Developed an operation model to provide capacity, headcount and operating cost estimates for multiple

p roducts and plant loading scenarios.

• Developed and implemented the overall commissioning plans for direct impact systems.

• Led the team that developed the high level Process Risk Assessment (FMEA) for critical processes.

• Developed process equipment scope and technology selection for the proposed pre-filled syringe line.

• Led design, procurement, startup and commissioning of a Hot Melt Extrusion processing line.

WYETH PHARMACEUTICALS, Carolina PR

Manager, Facility and Capacity Planning (May 2001 – August 2003)

Reported to the Process Excellence Director. Identified, developed and implemented business strategic initiatives

associated to capacity expansion, process optimization and new technologies.

• Participated with Corporate Technology in the conceptual design of a new lyophilized parenterals facility.

• Led the commissioning and startup efforts of the formulation, aseptic filling and CIP/SIP facilities and

equipment of a lyophilized parenterals facility expansion.

• Developed and implemented a comprehensive capacity simulation model to accurately predict attainable

p lant throughput, identify potential process constraints and determine strategic capital investments required.

• Led the implementation of a database system for generating and tracking manufacturing investigations that

h elped reduce lot release cycle times by 6 days, worth $500k in annual savings.

• Led a six sigma team to achieve a 20% improvement in lyophilizers reliability.

Senior Process Engineer / Process Improver (July 1997 – May 2001)

Reported to the Business Unit Director. Identified, developed and implemented new process equipment and

technology projects in the manufacturing and packaging areas to support plant volume increase.

• Developed and implemented constraint- based scheduling in the formulation, filling, lyophilization and

sealing areas, resulting in a 12% plant throughput increase, worth over $30MM in annual product sales.

• Led the procurement, commissioning, validation and startup of a state-of-the-art aseptic filling line.

• Worked together with corporate and outside firm engineers to develop the Master Plans for the site.

• Implemented and managed the plant- wide Key Performance Metrics balanced scorecard.

WILLIAM FUENTES July 2008 Resume: Page 2 of 2

RO-86 Urb. Riachuelo, Trujillo Alto, P.R. 00976 939-***-**** / 787-***-****

WORK EXPERIENCE AND ACCOMPLISHMENTS (Continued)

Process Engineer (November 1991 – July 1997)

Reported to the Operations Director. Provided technical and project management support to all manufacturing

p rocesses within the site in order to continually improve unit costs, quality, yields, capacity and cycle times.

• Implemented new autoclave, stopper processing, dry heat ovens, vial washing, sealing and packaging lines.

• Implemented various initiatives such as fill dose variability and overage reductions, filling parts cleaning

improvements, and setup reduction programs, resulting in improved yields and process capability.

• Developed plant- wide routings and line capacity utilization rates.

• Developed the Capacity Utilization and Process Technology portions of the Strategic Plan for the site.

DUPONT MEDICAL PRODUCTS, Manati, PR

Process Engineer (November 1989 – November 1991)

Provided technical support to the ACA and FLEX medical devices manufacturing operations.

• Performed startup and validation of the new facilities and automated production line to support the

accelerated transfer of the FLEX automated production operation (6 months before schedule),.

• Implemented various process improvement initiatives resulting in 33% yield loss reduction and 25%

d owntime reduction in FLEX manufacturing.

• Implemented the components QA Testing Lab and qualified new local vendors for packaging materials.

• Implemented a spreadsheet- based variable costs model for both product lines.

• As part of the MRP Core Team, led BOM accuracy team efforts toward successful Class A Certification.

GENERAL ELECTRIC, Reynosa, Mexico, Cincinnati, OH and Manati, PR

Materials Manager (July 1988 – November 1989)

Led the materials department. Responsible for materials planning and scheduling, receiving, shipping and inventory

control activities at the site. Directly supervised a total of 10 planners and material handlers

• Achieved plant quarterly sales and inventory goals.

• Led the successful transfer of 3 new product assembly lines.

• Implemented the MRP receiving module and improved BOM accuracy.

MMP Engineer (July 1986 – July 1988)

Completed one-year assignments in QC Supervision and Manufacturing Systems in two different locations.

• Supervised a crew of 8 unionized 2nd shift QC inspectors to execute the CFM-56 Jet Engine quality plan.

• Increased flexibility by implementing a cross-training program, resulting in a 30% overtime reduction.

• Completed phases II and III of the MRP implementation project ahead of schedule. Trained a total of 15

e mployees on the system. Developed documentation and procedures for all MRP system modules.

• Completed phase I of the Computerized Maintenance Management System project. This included the

d evelopment of the production equipment database and preventive maintenance plans.

CONTINUOUS EDUCATION

• Design Excellence (J&J Shared Services - Process Excellence, 2006)

• Barrier Isolation Technology Conference (ISPE, 2005)

• Six Sigma Black Belt Certification Training (Smarter Solutions, 2002)

• Management Development Curriculum (Wyeth, 2000)

• INTERPHEX / ISPE Seminars (International Society of Pharmaceutical Engineers (ISPE), 1997 – Present)

• Fundamentals of Lyophilization (Hull Corporation, 1996)

• Quality Auditor (CQA) certification (American Society of Quality, 1994)

• Quality Engineer (CQE) certification (American Society of Quality, 1990)

• GE’s Manufacturing Management Program (MMP) graduate (General Electric, 1988)

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