Validation & Engineering Group, Inc. Nov 2012 - May 2018
Validation Project Manager
Noven Pharmaceuticals Nov 2012 - May 2018
Qualification and Commissioning Manager
Top 500 Fortune Companies Jan 2000 - Dec 2017
Key Accomplishments
Selvalife Jun 2010 - May 2012
Plant Manager
Cima Healthcare Products Corp Jun 2006 - Dec 2010
Manufacturing Operations Director
Education:
University of Puerto Rico, Río Piedras 1999 - 2002
Master of Business Administration, Masters, Marketing, Management
Wentworth Institute of Technology 1984 - 1988
Bachelors, Bachelor of Science, Computer Science, Electronics Engineering
Skills:
P&L Six Sigma Quality Management Packaging Team Building Plant Injection Molding Lean Manufacturing Purchasing Industrial Engineering Cross Functional Team Root Cause Analysis Gmp Iso Start Ups 5S Warehousing Supply Chain Management Fmea Process Improvement Validation Materials Quality System Factory Operations Management V&V Manufacturing Management Cross Functional Team Leadership Manufacturing Change Management Fda Gmp Income Statement Manufacturing Operations Management Tqm Operational Excellence Product Development Kaizen Quality Control Kanban Pharmaceutical Industry Spc Process Engineering Supply Chain Continuous Improvement Capa Quality Systems Cost Reduction Fda Process Simulation Plant Management Iso 13485
Interests:
Animal Welfare Science and Technology Arts and Culture
Languages:
English Spanish
Certifications:
An Introduction To Operations Management An Introduction To Financial Accounting An Introduction To Marketing License X2Sdbym6Rm License Rkcwfxlnwf License 26Ghactgwk
May 2010 to Present Plant Manager, VP of OperationsTyco Healthcare and Covidien Operations Ponce, PR Aug 2005 to Dec 2009 Business Development and General ManagerCIMA Healthcare Las Piedras, PR, US May 2006 to Aug 2009 Site Director & Managing PartnerPharmaceutical Quality & Compliance Solutions Corp Caguas, PR Aug 2004 to Aug 2005 New Business Development/Managing DirectorMcNeil Consumer & Specialty Pharmaceuticals Las Piedras, PR, US Feb 2003 to Aug 2004 Site Project Manager - Rotor Granulator ConsultantALPHA Research & Consulting, Inc Humacao, PR, US Feb 2001 to Feb 2003 Validation & Qualification Services DirectorALPHA Research & Consulting, Inc
Feb 2001 to May 2001 New Business ManagerSmithKline Beecham Pharmaceuticals Co Cidra, PR, US Feb 1998 to Jan 2001 Senior Packaging EngineerSmithKline Beecham Pharmaceuticals LTD London Jun 1997 to Jan 1998 Core Team Member SB 10SmithKline Beecham Pharmaceuticals Co Cidra, PR, US May 1989 to Jun 1997 Manufacturing Engineer
Education:
The University of Puerto Rico Rio Piedras, PR 1999 to 2001 M.B.A. in Production Management & Marketing in Graduate School of Business Administration Joint ProgramUniversity of Louvain and Gante Sep 1990 to Aug 1992 Lean Manufacturing Certification in EngineeringWentworth Institute of Technology Boston, MA B.S. in Electronic Engineering and Computer Science
Skills:
Proficient in all aspects of regulatory and compliance agencies. Administration of operational plan budgets, population and volume analysis. Fully knowledgeable in Good Manufacturing Practices (GMP's), CAPA Investigations, Functional Requirement Specifications for Manufacturing, Engineering, MRPII Logistics, Cost Accounting, Purchasing, VCP, Quotation Analysis, Vendor Relations and Contractual Negotiations. Ability to work with various projects and priorities without conflict. Technical services background, Capital Project Management, Resources assignment, Scheduling, Troubleshooting. Design and implementation of new packaging strategies to reduce product cost or extend product shelf life. Full interaction with corporate marketing and packaging engineering groups. Expertise in all computer systems, bar coding and simulation software. Ability to develop and outline implementation plans for corporate strategies.