Leonardo Guzman, PE, PMPYorkshire Dr, Breinigsville, PA 18031

guzmanleonardo1@gmail.com • Cell 610-533-0212

 

Summary

Over fifteen years of experience in the pharmaceutical & biotech industry working as a Project Consultant. Demonstrated excellent performance in the planning & scheduling of EPC and C&Q Projects. Experience in the development of complex schedules using Primavera P6 & MS Project, critical path analysis, earned value, reports and metrics design.

 

 

Areas of Expertise

•Equipment Commissioning & Validation

•Knowledge in FDA requirements (21CFR-210 & 11)

•Schedule Development using Primavera P6 and MS Project.

•Analysis of Schedules using the Critical Path Method.

•Progress Measurement for Qualification and Validation Projects (Earned Value).

•Project Management.

•Portfolio Management

•Data Retrieval

•Pivot Tables-Excel

•P6 Analytics

•P6 Web

 

 

Experience

 

PPL Electric Utilities, Allentown, PA 12/2013 to Present

Lead Project Scheduler

•Oversee the Initial Baseline setup process, to be sure that all baselines are properly created and assigned.

•Provide Support to the PMs to create, maintain and update EPC project schedules throughout the project life cycle with accurate and timely data.

•Develop and maintain the Engineering Schedules for the Substation/Transmission Group.

•Develop metrics and reports to monitor the project portfolio performance against the baselines, keep track of projects at risk and inform the different stakeholders of any possible impact to the plan.

•Analyze schedules integrity using the Scheduler Checker tool and create activity codes & project codes values using the P6 web option.

 

 

McNeil, Fort Washington, PA 11/2011 to 11/2013

Scheduling Manager (PCM Consulting)

•Develop and maintain the Operational Readiness Schedule which included all the phases from Commissioning-Qualification-Validation up to the Product Validation and all the quality elements required by the Consent Decree to return the Plant to a GMP state.

•Develop metrics and reports to monitor the project progress and keep the project stakeholders informed. Optimize the resources utilization using the schedule information and provide progress updates for the activities in the critical path.

 

Merck, Lebanon, NJ06/2011 to 11/2011

Project Scheduler (Currie & Brown Consultant)

•Maintain and update the COMET Program Schedule (SAP Global Implementation plan).

•Develop a 4 weeks lookahead report and analyze the Critical Path for the project stakeholders.

•Follow up the schedule activities to assure on time execution and develop Progress Reports with the actual progress to present the project status to the project stakeholders.

 

Sanofi Aventis, Swiftwater, PA08/2009 to 06/2011

Project Scheduler (Oxford Global Resources)

•     Develop the Commissioning, Qualification and Validation Schedule (Resources Loaded) for a 160MM Building Renovation to increase the H1N1 Vaccine Manufacturing Capacity.

•Integrate the CQV Schedule to the Construction Schedule in order to analyze the Complete Schedule using the Critical Path.

•Develop the Preventive Maintenance Schedule of all the new equipment for the project.

•Develop the Planned Progress Plan and Staffing Plan using the Baseline Schedule.

•Develop Progress Reports with the actual progress using the earning value methodology (SPI, CPI, SV & CV) to present the project status to the project stakeholders.

 

 

Lilly del Caribe, Guayama, PR02/2009 to 08/2009

Validation Engineer (URS)

•Develop & Execute Commissioning and IOQ Protocols for a new Bulk Manufacturing Area with a DCS System (Delta V).

•Development and Execution of Commissioning & Qualification Tests for a new Purified Water System (Generation & Distribution System). The operational tests also included all the System Operation & Sanitization Sequences.)

•Development and Execution of Commissioning & Qualification Tests for a new Pressure Filter with all the DCS sequences associated with the equipment operation.

•Development and Execution of Commissioning & Qualification Tests for Reactors. The tests included installation and operation verifications for the ancillary equipments and instruments (flow-meters, pumps, jacket, agitators).

 

Wyeth Consumer Healthcare, Guayama, PR08/2007 to 02/2009

Project Scheduler

•Work in the development and maintenance of different Construction Projects Schedules including the FAI-008 project (90MM).

•Provide Schedule control and follow up the different team members to ensure the completion of the critical activities according to the baseline schedule.

•Develop Monthly Reports & Cost Control Report to inform the Project Status to the projects stakeholders.

 

Amgen, Juncos, PR03/2007 to 08/2007

Project Engineer

•Support the AML-1 Fill & Finish Plant in the Change Control Process

•Create and follow up the complete Change control cycle using the CCMS (Change Control Management System).

•Generate the Work Orders associated with the change control activities using the CMMS (Computer Maintenance Management System).

 

Wyeth Pharmaceuticals, Guayama, PR01/2006 to 03/2007

Senior/Equipment Process Engineer

•Support the Rapamune Manufacturing Area in the Equipment Validation, Process Validation and in the manufacturing daily activities.

•Develop new PM instructions for different pharmaceutical equipment (Blenders, Coater, Tablet Press, Roller Compactor)

•Develop & Execute Process Validations after modifications to a Pellegrini Coating Plan and a new Bin Blender installation.

•Change Controls and Manufacturing Investigation Reports including the CAPA (Corrective Action Preventive Action) analysis using Track Wise system.

 

Wyeth Pharmaceuticals, Guayama, PR11/2003 to 01/2006

Project Leader (Washington Group)

•Project Manager Functions: Scope Planning, Schedule Development, Cost Budgeting, Staffing Plans and Progress Reports (Earned Value).

•In charge of the development and execution of the Qualifications for the Librel Project (Facilities, Roller Compactor, Tablet Press, Bin Blender) associated to a pharmaceutical area.

•In charge of the development and execution of the Qualifications for the Effexor Project. Other responsibilities included:  Development and execution Installation and Operational Protocols for Plant Utilities (Nitrogen, Plant Air, HVAC, USP/EP water).

 

Merck Sharp & Dohme, Barceloneta, PR11/2000 to 11/2003

Process Engineer (Washington Group)

•          Support the Technical Operation Department during the MK-663 and Enalapril Projects.

•Development of new Preventive Maintenance instructions for chemical plant equipment (tanks agitators, centrifugal pumps, vacuum pumps, diaphragm pumps etc).

•Development and execution of the Commissioning Tests & Operational Qualifications for chemical plant equipment (Reactors, Crystallizers, Flow Meters, Centrifugal and Diaphragm pumps, Pressure Filters, and DCS sequences.

•Development of Manufacturing Batch Records for the MK-663 and Enalapril manufacturing process.

 

Abbott Laboratories, Barceloneta, PR05/1999 to 12/1999

Coop Engineer

•Development of Preventive Maintenance Instructions and execution of Installation Qualification Protocols for pharmaceutical equipment (Fluid Bed Dryers, Particle Coater, Grals)

 

 

Education

University of PR, Mayagüez Campus

BS in Mechanical Engineering05/2000

 

 

Licenses & Certifications

Professional Engineer License-Pennsylvania State-PE077999-(NCEES Record available)

Professional Engineer License-Puerto Rico-18443

PMP Certified & Member of the National and the Pennsylvania Society of Professional Engineers

 

 

Training

FDA Inspections Readiness for CSV and 21 CFR Part 11: Electronic Records and Electronic Signatures

Kepner Tregoe Problem Analysis

MS-Project, MS-Word, MS-Power Point, MS-Excel

HVAC Validation, Water System Design

TrackWise (Event, Manufacturing Investigation Reports and Change Control)

Basic PLC’s, Micro PLC’s Maintenance & Troubleshooting

CMMS (Computer Maintenance Management System), CCMS (Change Control Management System)

PrimaveraÒ Contractor, Project Management