Education

1994-1999
BS Chemistry

Professional Experience

2008 to present

Senior Consultant, Confidential, Puerto Rico

Confidential

• Principal job responsibilities include the development of Specific Requirements, Software Testing, Validation Deliverables and Configuration for the Manufacturing Execution System (MES - CamStar InSite 2.4) software at Cordis, San German.
• Support Manufacturing Engineers with the MES system integration effort.
• Support Software Engineers to perform Software Testing and Installation for a Human Machine Interface (HMI) as part of the MES/HMI-Spray Coating Cart project. HMI software and interface developed using Wonderware applications (ArchestrA and InTouch).
• Work in collaboration with Software Engineers to perform PLC Program routine changes and download using RSLogix 5000 software.
• Provide consultant support in the development of Specific Requirements and Software Testing for Cognos 8.4 software.
• Experience working with JD Edwards and other MES interfaces.
• Support Manufacturing Engineers revising Program Requirements Specification and creating Validation Deliverables for the InfinityQS SPC System version 01 & 02.
• Experience working with the Software Development Life Cycle (SDLC) methodology.

2005 to 2008

Senior Consultant, Confidential, Puerto Rico

Confidential

• Perform multiple Computer System Validation projects at Cordis, San German.
• Experience developing and executing Validation Deliverables (Validation Strategy, System Requirements Specification, Software Installation Protocols/Reports, Validation Protocols/Reports, Traceability Matrix, Installation and Operational Qualification Protocols, Part 11 Assessments and Final Compliance Reports) for Business, Laboratory and Manufacturing Systems.
• Experience creating and developing Deviation and Discrepancy reports.
• Experience performing CSV Remediation (Gap Analysis) for Business, Manufacturing and Laboratory systems.
• Experience in the development of FMEA, Corrective Action Plan, Risk Based Analysis, Change Control Request and Closing Report for Business, Laboratory and Manufacturing Systems.

Cordis, Juarez, Mexico, LuMend Transfer Project (California to Mexico)

• Principal job responsibilities include full system validation (Validation Deliverables creation and execution) of a COTS Configured software (Harland Friction Tester FTS 5000) using J&J CSV Methodology.

Cordis, Miami Lakes FL (Medical Devices Industry)

• Principal job responsibilities include the Evaluation and Remediation of Business and Manufacturing Systems at Cordis, Miami Lakes, FL.

2003-2004
Senior Consultant,Confidential, Puerto Rico

Confidential (December 2004 – December 2005)

• Principal job responsibilities include the Evaluation and Remediation of Manufacturing Process Equipment for the Pharmaceutical and API Plant of Schering-Plough, Manatí Site.
• Development of IOQ protocols for Analytical Laboratory equipment.
• Experience performing Manufacturing Process Investigations for an API plant.
• Development and Implementation of CAPA related to Process Engineering in an API Plant.
• Experience working with Change Control for Corrective Actions implementation.

2002-2003
Validation Specialist, Confidential, Puerto Rico

Confidential (May – September)

• Principal job responsibilities include the development of IOQ protocols for the Validation of Equipment (Fermentation Tanks, Oxidation Tanks and Buffer Hold Tanks).
• Experience in the assessment of Process & Instrumentation Diagrams (P & IDs).

Confidential(September – April)

• Principal job responsibilities include the development and revision of SOP’s using GMPs and Worldwide Quality Standards for Packaging, Manufacturing, Regulatory Affairs, Analytical Laboratories and other plant departments.

2002-2002
Confidential

• Principal job responsibilities include the analysis of oral dosage solid products using diverse analytical laboratory instrumentation and techniques.

• Principal job responsibilities include the analysis of lyophilized (Parenterals) products using a variety of laboratory instrumentation and techniques.
• Experience in the development of Analytical Laboratory Investigations and CAPA.
• Experience developing, writing and revising SOP’s for Analytical Laboratory Instrumentation.

1998-2000
Confidential

• Organic Synthesis via organoboranes and other organometallic compounds.
• Experience in the preparation and handling of air sensitive compounds (organoboranes and borohydrides) and their analyses through 11-B NMR.
• Analysis of reaction mixtures using GC and GC-MS.

Instrumentation and Laboratory Skills

• Trained in acquiring and analyzing data using GC, GC-MS, FT-IR, HPLC, UV, Polarimetry, Electrophotometry and Karl Fisher titrators.
• Trained in acquiring and analyzing data using Beckman LIMS, Labware LIMS, SQL*LIMS, Peak Pro and Turbochrom.
• Experience using Dry Box and Schlenk-tube techniques for handling air and moisture sensitive material.
• Trained in Profile and Manual Dissolution Techniques.
• Experience working with Parenteral and Lyophilized products.
• Experience working with Oral Dosage Solid products.
• Strong knowledge of GMPs and GLPs.

Manufacturing, Business and Laboratory Systems

• Manufacturing Execution System (MES) – CamStar InSite 2.4 (Manufacturing)
• Cognos BI 8.4 (Manufacturing)
• SmartScope Flash 250 – Measuremind 3D Multisensor Software, version 13.01 (Business)
• Logware Software, version 1.3 (Business)
• Aalborg DFM Control Terminal Software, version 1.01 (Business)
• Labware LIMS (Laboratory Information Management System), version 5.0.2k (Laboratory)
• Karl Fisher Titrator (Laboratory)
• HP Gas Chromatograph (Laboratory)
• TempTale Manager software, version 4.2 (Business)
• InfinityQS software - Statistical Process Controller (Manufacturing/Business)
• Hydraulic Burst Leak Tester (Manufacturing)

Other Skills

• LIMS Labware Certified.
• Trained in KEPNER-TREGOE.
• Experience using TrackWise software.
• Computer Literate (Windows, Word, Excel, Power Point,etc).
• Fluent in Spanish and English.

Presentations