Career Summary

Engineer with over thirty-six (*6 ) years of growing responsibilities in a variety of managerial/supervisory positions in the Pharmaceutical and Consumer Operations. Over four (4) years of proven experience in the successful implementation of SAP (System Application and Product), Expert in SAP system in the modules PP and PP/PI (Including Master Data, Work Centers, Resources, Bill of Material, Routing, Master Recipe). Leader with proven record of achievements in Manufacturing Manager, Project Manager, New Product Manager, Continuous Improvement, Operational Excellence Tooling, No Conformance Investigation, CAPA Implementation, Change Control Process, Manufacturing Support, Troubleshooting and Industrial Engineering. Experience in validation process revision and execution IQ, OQ and PQ protocols for manufacturing equipment, manufacturing processes, utilities, and facilities. Execute assigned validation activities for the site plants. Design and implementation dashboard to ensure the progress of the goals is maintained and the expectation of the management are met. Experience to work in conjunction with the validation team to keep updated the validation master plans. Strong expertise in budget preparation for manufacturing and packaging departments, cost improvement implementation, standard evaluation, and Re-engineering process.

Knowledge in Manufacturing and Packaging equipment, processes, and capacity analysis; This includes the following Manufacturing and Packaging equipments: Fluid Bed Dryer, V-Blende, Bin Blender, Imatic Capsule Filling, Kikusui and Killiam Compressing Machines, Bottle Line, Blister Machine, CP10, Uhlmann L, Uhlman 1030, CP600, Poucher, Alloyds, Carding Machines and Overwraps.

Strong knowledge in Microsoft Office (Word, Excel, Power Point, MS Project, Pivot Table). Strong knowledge in trackwise investigation program. Certified Kepner Tregoe, Lean and Six Sigma Tools, Green Belt, Management Certification Program for Managers and Supervisors, Process Expert. Strong communication and interpersonal effectiveness. Unique experience in giving support to manufacturing area during the evaluation of Sub-part D to successfully overcome a Plant Certification Inspection by the FDA.

Accomplishments

A multi-skilled professional with a track record of managing complex functional project in various environments. Strong Project Manager Knowledge and successfully Project implementation.

Maintain the SAP system for the Global Operations in a Customer Pharmaceutical Industry. Expert in Master Data, Bill of Material, Work Center/Resources, Master Recipe/Routings, Productions and change control in SAP system.

Prepare an Operations Budget (Including Manufacturing and Packaging Department) for a Customer Pharmaceutical Industry.

Executed continuous improvement and Operational Excellence implementation in the pharmaceutical plant.

Successfully Manufacturing Plant Management and New Technology Implementation.

Successfully full cycle designed and implemented SAP integrated software system for three plants operations in Puerto Rico and Ringaskiddy, Ireland (manufacturing execution and master data).

Successfully led product transfer projects to Manufacturing Plant in a Pharmaceutical Company.

Designed and implemented indicator system for the manufacturing and packaging department.

Professional Experience

Independent Consultant July 2009 – January 2024

Consult with companies to provide expertise in the areas of Operations, Manufacturing or Packaging Manager and Supervisor, Project Management, SAP implementation, Operational Excellence, Process Improvement, Lean Six Sigma, Budget Preparation, Capacity Analysis, Standard Preparation, Key Performance Indicators, Line Balancing, Standard Preparation and Environmental Health and Safety Representative or Manager. Major Engagements:

E. Donate Real Estate: October 2006 – Present

Responsible for marketing listing and provide guidance to buyer, seller and purchasing property for the right price under the best terms.

Stryker thru MG Staffing Group

Sustain Project Manager. Responsible for operation support as Project Manager. Create and lead the team, monitor projects deadline, create a project timeline to avoid business interruption.

Amgen thru Alpharma Integrated solution

Supply Chain Manager. Responsible for operation support of equipment and facilities in AML5 building as a Project Manager. This includes the execution support of installation, operations, and qualifications (IOQ) of equipment and facilities.

inverSOL:

Responsible for the operation functions tasks including, planning, organizing and directing the operation activities through to final inspection stage as a Production Manager.

Stryker thru Kelly:

Responsible for the Manufacturing Operations as a Production Supervisor.

Bristol Myers Squibb thru Weil Group:

Responsible for the Packaging Technology and Warehouse Projects as a Project Manager in Manati facility. Work in validation of serialization process in Pharmaceutical Industry to tracing each individual product via a unique serial number from a manufacturer right through to the end used in Packaging Area.

PWF Cidra:

Responsible for engineering and construction projects by planning, organizing and controlling all elements of the project. Supervises all development and implementation of a project.

Coca Cola Bottle:

Responsible for engineering and construction projects by planning, organizing and controlling all elements of the project. Supervises all development and implementation of a project.

Techno Plastics Industries:

Responsible for the Production operation as Production Manager. Provide guidance to production processes in order to ensure that production, quality / regulatory customer service requirement is met.

Frito Lay thru Adecco:

Supervise the daily work schedule of warehouse employees involved in performing a combination of shipping, receiving, loading, and unloading trucks, stacking, picking and palletizing finished products. Ensures the warehouse equipments maintenances are working properly and safety.

Janssen thru Kelly OCG:

Develop the EHS and Compliance department in Janssen Kelly OCG Warehouse Outsourcing. Design content and coordinate training for EHS and compliance audit administration.

Bristol Myers Squibb thru AEROTEK:

Responsible for the Project Manager in Manati and Humacao facilities in MAKE project and maintain the master data, resources, bill of material and master recipe in SAP system.

Warner Chilcott thru Mentor Technical Group:

Provide leadership to support Continuous Improvement, Operational Excellence, analyzing, designing, and implementing manufacturing and business process improvements. Maintain the Key Performance Indicators (KPI) in the Plant and gold metric. Responsible for time study analysis, prepare capacity analysis and prepare manufacturing and packaging budgets. This includes the following Manufacturing and Packaging equipments: Fluid Bed Dryer, V-Blende, Bin Blender, Imatic Capsule Filling, Kikusui and Killiam Compressing Machines, Bottle Line, Blister Machine, CP10, Uhlmann L, Uhlman 1030, CP600, Poucher, Alloyds, Carding Machines and Overwraps. Developed reports and indicators to measure plant performance.

OSRAM SYLVANIA COMPANY

EHS and Safety Engineer and Project Engineer Leader April 2008-May 2009

Luquillo Plant

In charge of the development, coordination, and administration for the complete EHS Luquillo Site Plant.

Responsible for compliance with all regulations on the Safety, Environmental, Health and Site Security scope.

Responsible to perform EHS audits to identify noncompliance areas and implement corrective actions.

In charge of the engineer process improvement and project engineer. Also performing as Acting Quality Manager from September 2008 to May 2009.

WYETH PHARMACEUTICAL COMPANY

Manufacturing Manager May 2004-March 2008

Guayama Plant

Lead the manufacturing operation managing over 80 colleagues through four (4) direct supervisors.

Lead the manufacturing function within budget and output target to meet customer requirements and standards.

Responsible for the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives.

Partner with Planning and Material team to develop production schedules based on equipment efficiency, and materials supply.

Prepare budgetary recommendations on capital expenditures and direct/indirect labor. Lead the facility readiness for regulator inspection. Revised and lead the execution of IQ, OQ and PQ protocols for validations processes.

New Product Manager January 2003-May 2004

Guayama Plant

Lead Manufacturing Site Team, for the introduction of DVS product.

Lead technology transfers, system specifications, validation plans and evaluation of standard operating procedures related to manufacturing processes, products and contract clients with Global Team Leader.

Manage the schedule of products introduction and Site to Market launches.

Coordinate projects and follow-up on action items to meet timetables in compliance with GMP'S, SOP'S and regulatory standards and requirements. Server as a point person for internal and external group to market Launch.

Revised and lead the execution of IQ, OQ and PQ protocols for validations processes. Also worked as Acting Manufacturing Manager from 2003 to 2004.

Manufacturing Supervisor December 2000-December 2002

Guayama Plant

Supervise the process of capsule filling and inspection during the first shift. Coordinate, organize and supervise manufacturing operations according to production schedule.

Assure department operations compliance with GMP’S, SOP'S and regulatory standards and requirements.

Provide troubleshooting support to assure manufacturing equipment optimum conditions. Perform manufacturing investigation reports and recommend actions to be taken in the three manufacturing shifts.

Lead the execution of IQ, OQ and PQ protocols for validations processes. Also performed as an Acting Manager while the manager is on vacation or assigned to other duties.

WARNER-LAMBERT, INC.,

Business Process Consultant-SAP Integrated Software May 1996-November 2000

Vega Baja and Fajardo- Pharmaceutical and Consumer Division

Led activities related to the Manufacturing/Production execution and business process in a highly integrated environment.

Developed and conducted training for key users on new SAP system.

Implemented technology for Quality, Time and Cost measuring, and promoted and supported technology improvement process. Directed team to ensure the successful SAP upgrade implementation of the manufacturing execution, master data modules and plant maintenance, from supplier to customer in the release 4.6B.

Lead two successful SAP implementations of the manufacturing execution and master data modules, from supplier to customer, in the release 3.0F in Ringaskiddy, Ireland and 3.0D in Puerto Rico.

Manufacturing Engineer November 1994-May 1996

Vega Baja, Puerto Rico Pharmaceutical Division.

Designed, developed, and implemented new technology for the manufacturing areas.

Recommended procedures to improve plant efficiency.

Developed reports and indicators to measure plant performance.

Led the cost improvement implementation.

Supported the manufacturing manager in the development of departmental budget. Developed and revised standards for products in the Pharmaceutical Plant. Support the Manufacturing shutdown in Manufacturing Area.

Manufacturing Supervisor February 1992-November 1994

Vega Baja, Puerto Rico. Pharmaceutical Division.

Supervised the process of compressing, capsule filling, coating, printing, and inspection areas.

Coordinated, organized and supervised manufacturing operations according to production schedule.

Assured department operations compliance with cGMP'S, SOP'S and regulatory standards and requirements.

Provided troubleshooting support to assure manufacturing equipment optimum conditions.

Also supervised all tooling activities for the drying, milling, blending, compressing, capsule filling, coating and tablet imprinting. Coordinated planning of tooling usage, budgets and proper tooling maintenance.

Also worked as Acting Manufacturing Engineer from October 1994 to November 1994.

Granulation / Tableting Foreperson December 1989-February 1992

Vega Baja, Puerto Rico. Consumer Division.

Assigned daily work to granulation area operators and service personnel.

Monitored quality and quantity of work to assure proper product documentation in accordance with the cGMP’s.

Established daily priorities for compressing machine. Monitored granulation and packaging areas work to assure proper coordination between day and night shifts in accordance with cGMP'S.

Education

University of Phoenix

Puerto Rico Campus

Master of Business Administration

University of Puerto Rico

Mayagüez Campus

Bachelor’s degree in industrial engineering

Puerto Rico Licensed Engineer in Training

Puerto Rico Real Estate Licensed

Memberships

• College of Professional Engineers and Land Surveyors of Puerto Rico, San Juan Chapter

• Institute of Industrial Engineer

• Zeta Phi Beta Fraternity

PROFESSIONAL CERTIFICATIONS

Puerto Rico Licensed Engineer in Training

Puerto Rico Real Estate

Certified Kepner Tregoe

Lean and Six Sigma Tools

Green Belt

Management Certification Program for Managers and Supervisors

Email: ad3a6u@r.postjobfree.com

Mobile: 787-***-****

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