## BIO
Over thirteen (13) years of experience in the pharmaceutical/biotechnology industry, with strong emphasis in the validation of computerized systems, utilities, manufacturing processes, process equipment (IQ/OQ/PQ) and cleaning processes. • Experienced as a Quality Assurance (QA) professional in the development, review, approval and execution of computer system validation (CSV) documentation to support GxP applications. • Experienced in audits of software vendors and Clinical Research Organizations (CRO) that use information systems to support their regulated activities. • Skilled in the assessment of information systems for compliance with 21 CFR Part 11 and GAMP guidelines. • Project Manager for the implementation of several GxP applications (WATSON Laboratory Information Management System (LIMS), SkillPad-Learning Management System (LMS)) • 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). • Strong training and mentoring skills. • American Society for Quality (ASQ)- Certified Software Quality Engineer (CSQE) EDUCATION Ph.D. Information Systems Pursuing a Ph.D. in Information Systems at Nova Southeastern University (2005-Present) M.S. Management Information Systems Kean University, New Jersey, January 2002 B.S. Chemical Engineering University of Puerto Rico, Puerto Rico, December 1993 PROFESSIONAL EXPERIENCE ImClone Systems Inc. – Somerville, New Jersey 2000 to Present Senior Computer Validation Engineer III-Quality Assurance (6/2005 to Present) • Responsible for the project management, implementation and validation of GMP/GCP enterprise information systems (Watson Laboratory Information Management System (LIMS), Trackwise applications , SkillPad Learning Management System (LMS)) including but not limited to training of contractors, review and approval of project validation documents. • Responsible for providing technical and regulatory guidance in the area of computer systems validation and 21 CFR Part11. • Responsible for the review/approval of computer systems validation and software development documents related to information systems with GxP impact. • Member of the software vendor audits team that supports computer systems validation activities and CRO’s. • Responsible for the evaluation of changes to qualified computer systems. • Trackwise Change Control System Administrator. Senior Computer Validation Engineer II-Quality Assurance (11/2004- 6/2005) • Responsible for the Validation of computer based systems in the Quality Assurance and Clinical areas. • Responsible for 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. • Responsible for evaluating changes to qualified computer systems. Senior Computer Validation Engineer II (4/2003- 11/2004) • Generated and executed protocols for the installation of remote printers for a PLC based Clean in Place (CIP) skid. • Member of the 21 CFR Part 11 Assessment team responsible for the 21 CFR part 11 assessments of the Manufacturing, QC and QA areas. • Generated and executed protocols to support changes to the Manufacturing Building Management System (BMS). • Directly involved in the development and execution of computer system protocols to support the installation and operation of several Honeywell paperless chart recorders. • Responsible for the supervision of validation consultants working on several GMP projects. • Developed databases to keep track of the Validation documentation and protocol discrepancies. Validation Engineer II (10/2000-4/2003) Utilities Validation, Process Validation, Equipment Validation: • Participated in the start-up of a biotech manufacturing facility. • Supervised validation contractors working in the Quality Control (QC) area. • Generated and executed Validation protocols for the qualification of utilities (Purified Water, Water for Injection, Clean Steam, and Compressed Air), process equipment and support equipment. • Generated and executed Validation protocols for the qualification of Steam in Place (SIP) and Clean in Place (CIP) processes. Computer Systems Validation/21 CFR Part 11: • Participated in the 21 CFR Part11 compliance assessment team. • Generated and executed Validation protocols for the PLC and software upgrade of several chromatography skids. • Involved in the execution of Validation protocols for the Honeywell paperless chart recorders. Schering Plough – Kenilworth, New Jersey 1997 to 2000 Associate Validation Engineer/Validation Engineer I (6/1997-9/2000) • 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. Schering Plough – Manati, Puerto Rico 1994 to 1997 Chemical Plant Technical Assistant (2/1994-5/1997) • Provided technical assistance to the Antibiotics Chemical Plant manufacturing supervisors. • Served as a liaison between the Chemical Plant and the support departments like 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. • Provided support to the Antibiotics plant production planner. TRAINING Project Management Seminar Series (Stevens Institute of Technology) ImClone Systems Incorporated, January-February, 2007 Total Quality Management (TQM) ImClone Systems Incorporated, October, 2006 PLC Fundamentals Rockwell Automation, Tampa, August 2006 Project Management Workshop Kepner Tregoe, New Jersey, May 2006 Computer Systems and Software Validation Conference IVT, San Francisco, August 2005 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 Compute
## Area of Expertise
Software Quality Assurance/ 21 CFR Part11 Testing Software Vendor Audits Software in the Bio-pharmaceutical arena Software Compliance
