Over fourteen (14) years in the bio-pharmaceutical industry, with strong emphasis in the implementation, validation and compliance of Information Systems in an FDA regulated environment. Experienced as a Quality Assurance (QA) professional in the development, review and approval of computer system validation (CSV) documentation. Skilled Information Systems auditor with experience in compliance with 21 CFR Part 11, GAMP guidelines, computer validation and Information Technology infrastructure. Experienced with the implementation and validation of information systems including but not limited to Trackwise, ARISg, Pilgrim, Documentum, SkillPad, Empower Chromatography Systems, Programmable Logic Controllers (PLC’s) and Building Management Systems (BMS). Certified Software Quality Engineer (CSQE)-Certification # 3737. Bilingual (English/Spanish). Recipient of 2005 Extraordinary Effort Award.
CARES Administration Business Manager – Bristol-Myers Squibb, Hopewell, NJ 2007-2008
• Developed metrics reports to analyze and distribute help desk tickets assigned to the CARES Administration group personnel.
• Reviewed, approved and implemented configuration changes for a global adverse event reporting application.
• Configured and tested E2B accounts for the electronic submission of Individual Case Safety Reports (ICSR) from/to Bristol-Myers Squibb partners and Regulatory Health authorities such as the FDA and the EMEA.
• Integral part of the analysis and design of a new web-based application intended to maintain and track Bristol-Myers Squibb pharmacovigilance reporting responsibilities.
Quality Assurance Sr. Computer Validation Engineer III-ImClone Systems Inc., Somerville, NJ 2000-2007
• Managed the implementation and validation of GMP/GCP enterprise information systems (Watson Laboratory Information Management System (LIMS), Trackwise applications, SkillPad Learning Management System (LMS)). Responsibilities included training of contractors and the review and approval of project validation documents.
• Performed several software vendor audits focusing on compliance with 21 CFR 11, computer validation and IT infrastructure requirements.
• Handled the quality assessment of Computer System Validation documentation such as System Validation Plans, User Requirements Specifications (URS), Detailed Design Specifications (DDS), Functional Requirement Specifications (FRS), Validation Protocols (IQ, OQ, PQ), Traceability Matrix and Summary/Final Project Reports used to support the implementation or maintenance of computer validation systems.
• Generated and executed protocols for the installation of remote printers for a PLC based Clean in Place (CIP) skid and Manufacturing Building Management System (BMS), qualification of utilities (Purified Water, Water for Injection, Clean Steam, and Compressed Air), process equipment, support equipment, Steam in Place (SIP), Clean in Place (CIP) processes and chromatography skids.
• Supervised and mentored contractors responsible for the assessment of computer systems for 21 CFR11 compliance, validation of Quality Control equipment and several other GMP projects.
• Participated as validation representative in the successful start-up of a biotech manufacturing facility.
Validation Engineer –Schering Plough, Kenilworth, NJ 1997-2000
• Generated and executed validation protocols for the qualification of Clean in Place (CIP) processes in the Liquids Ointments and Creams and Aerosols areas.
• Generated and executed process Validation protocols for the Liquids Ointments and Creams area.
• Generated and executed Validation protocols for the qualification of autoclaves and dryers using Kaye temperature-mapping device.
• Developed a database application to keep track of the Validation Department internal documentation.
Antibiotics Manufacturing Plant Technical Assistant –Schering Plough, Manati, PR 1994-1997
• Provided technical assistance to the Antibiotics Chemical Plant manufacturing supervisors.
• Served as a liaison between the Chemical Plant and support departments such as Engineering, Quality Control, Process Support and Quality Assurance.
• Generated manufacturing process protocols, observation/deviation reports, standard operating procedures (SOP’s) and documentation related to the Antibiotic manufacturing processes.
• Provided GMP, safety and environmental training to operators, and manufacturing supervisors.
Ph.D. Information Systems Expected Graduation 2010
Nova Southeastern University, Florida
M.S. Management Information Systems 2002
Kean University, New Jersey
B.S. Chemical Engineering 1993
University of Puerto Rico, Puerto Rico
• Validating Clinical IT Systems / Auditing Clinical IT Systems
Regulatory Compliance Workshop Group, Washington, DC, July 2007
• Project Management Seminar Series (Stevens Institute of Technology)
ImClone Systems Incorporated, January-February, 2007,
• Total Quality Management (TQM)
ImClone Systems Incorporated, October 2006
• Project Management Workshop
Kepner Tregoe, New Jersey, May 2006
• Computer Systems and Software Validation Conference
IVT, San Francisco, August 2005 and Washington, April 2002
• Complying with Computer and Software Validation Requirements
PTi International, Philadelphia, September 2004
• Risk Assessment for Computer Systems Validation and 21 CFR part 11
ImClone Systems Incorporated, June 2003
• Validation of Computer Systems: Pharmaceutical R&D
Center for Professional Advancement, New Jersey, June 1999