Background
Experienced Information Technology and Validation Specialist with knowledge in compliance regulations and technology within the Pharmaceuticals and Medical Device Industries. Expertise in Computer Systems Validation and implementations for the Laboratory and Manufacturing infrastructures.

Expertise Highlights

• Computer Systems Validation (IQ,OQ, PQ, UAT and Test Scripts documents)
• Business Systems Analysis and implementations
• Technical Writing (Manuals/System Specification and Procedures)
• Systems Security Policies and Disaster Recovery Planning
• Application Technical Support

Work Experience

• Managed corporate application migration and validation to comply with SOX, COBIT and COSO guidelines. Design and coordinate User Acceptance Tests Scripts to ensure compliance.
• Worked in the Johnson & Johnson Medical Caribbean Regional Office 2007 and Windows Vista Migration Project as a Project Coordinator. Planning and scheduling migrations for users throughout Caribbean and Central America countries. In addition, worked in application inventory and migration remediation of compatibility for the new operating system.
• Managed data migration from corporate eRooms into SharePoint Portal. Administered users security and data quote size.
• Worked with Johnson & Johnson and Schering Plough Pharmaceuticals in Puerto Rico to developed regulatory strategies for compliance with CGMP, FDA (21 CFR Part 11, 210, 211 and 820), GAMP Guidelines and Company Internal Regulations for Laboratory and Manufacturing systems.
• Computer Systems Validation Team Leader for infrastructure qualification projects with team members assigned. Participate in decision making for project documentation deliverables to ensure compliance with applicable regulations and strategies to enhanced project qualifications timelines. Motivated members to perform high quality documentation in a timely manner.
• Assisted on infrastructure qualification projects during the plant startup phase for Laboratory Information and Manufacturing Execution Systems. Provide guidance to applications and support team members on impact related changes to current infrastructure validation state with software or hardware related activities.
• Participated in validations for Glatt, FETTE, HVAC, HMI, VMS/VAX and Tablet tester systems.
• Assisted in the implementation, development and execution of several Infrastructure Qualifications documents (Validation Plan, User Requirements, Functional Requirements, Technical Specifications, Traceability Matrix, IQ/OQ/PQ protocols and Summary Reports) for the following Infrastructure installed:
• High Availability Systems Infrastructure (MS Windows, Citrix and HP-UNIX platforms with Oracle and SQL databases)
• Laboratory Information Management System (LIMS) Infrastructure
• Manufacturing Application System Infrastructure
• Citrix Farm Servers Infrastructure
• Data Center Infrastructure Qualification
• Cisco Internetworking Infrastructures Technologies.
• MES (Manufacturing Execution System) Infrastructure for Production, Quality and Development Environments.
• Electronic Batch Record System with SAP system
• MAXIMO application infrastructure
• Author and technical writer of many Standard Operating Procedures (SOPs) for several clients' with diverse Infrastructures
• Author of the Computerized Security System Audit Reports
• Experienced in the creation and review of Change Requests for additions, modifications and retirement of systems for Laboratory and Manufacturing Infrastructures.
• Managed in the creation of the nationwide DRP (Disaster Recovery Plan) for Johnson & Johnson Pharmaceuticals.
• Performed assessments of all Infrastructure Qualification documents to ensure compliance with GxP regulations for FDA and CAPA audits performed.
• Worked in the Johnson & Johnson Windows 2000 Migration project nationwide.

LAN Administrator
Confidential, Guaynabo, PR
06/1997 - 11/2001

• Manage and support Local Area Network (LAN) activities.
• Responsible for planning, installing and maintaining all network activities throughout several facilities.
• Develop database applications for several departments and projects within the corporation.
• Ensure data disaster recovery procedures work through frequent testing and analysis.

Education

Degree in Computer Programming
Member of the Honor Society
Studies in BS in Information Technology

Trainings
Pharmaceuticals, Puerto Rico

• Introduction to cGMPs
• Comunicando Experiencias Adversas del Producto (Adverse Product Experiences Communication)
• Computerized Systems Validation
• ITS-PR Infrastructure Qualification Methodology
• Computer Systems Implementation Process (CSIP) Training
• GxP Awareness Training
• Policy on Business Conduct
• eSignature Verification
• Global Compliance Training Policy
• Information Asset Protection Policies Awareness Training
• General Audit / Inspection Readiness Training
• Sarbanes-Oxley (SOX) Awareness
• Introduction of GAMP Regulation
• Computer and Automated Systems Life Cycle Approach to Validation
• Electronic Records and Electronic Signatures (21 CFR Part 11)
• GxP Applicability Assessment for Computer and Automated Systems
• System Validation for Legacy Computer and Automated Systems
• Computer and Automated Systems Retirement
• Design Specification for Computer and Automated Systems
• User Requirements and Functional Requirement Specifications for Computer and Automated Systems
• Computer and Automated Systems Life Cycle Approach to Validation
• Guidelines for Network Infrastructure Qualification
• Guidelines for Server Qualification

New Horizons - Guaynabo, PR
Interconnecting Cisco Internetworking Devices (ICND) course
Educational Computer Center - Carolina, PR
Microsoft Certified System Administrator (MCSA) course
Professional Education Center - Hato Rey, PR
Certified Information System Auditor (CISA) course
Computerized Based Trainings

• Cisco Certified Network Associate (CCNA)
• Cisco Certified Design Associate (CCDA)
• ComTIA Network +
• ComTIA Project +
• Project Management Professional (PMP)
• Microsoft Certified Systems Engineer (MCSE)
• Microsoft Certified Systems Administrator Server (MCSA)
• Microsoft Windows Operating Systems
• VMWare Infrastructure
• Microsoft Office
• Microsoft Visio
• Microsoft Project
• Information Technology Infrastructure Library (ITIL)
• Microsoft Access

Regulations
Knowledge of:

• FDA Regulations (21 CFR Part 11, 210, 211 and 820)
• ISO 9000 Standards
• PIC/S Guides as applicable to CGMP and Computer System Validation (Good Practices for Computerized Systems in Regulated GxP Environments)
• GAMP Guidelines and Testing of GxP Systems
• FDA Guidance on Software Validation
• Sarbanes-Oxley (SOX) Act
• Control Objectives for Information and related Technology (COBIT)
• Committee of Sponsoring Organizations of the Treadway Commission (COSO)

Skills & Certifications

• Knowledge of computer hardware and software, network topologies, LAN/WAN, and Internetworking technologies.
• Knowledge of document management systems like: Documentum, Trackwise, iLib and HP Quality Center.
• Ability to design, installs, configure, troubleshoot, and maintain networks and access services.
• Possess understanding of corporate reporting structure, including chain of command for use in problem escalation, major outage notifications and change coordination.
• Project management ability to deal effectively with people in a courteous and tactful manner that promotes supportive service at all time.
• Knowledge of Clustering Server Technologies (Network Load Balancing Clustering, HP ServiceGuard and Microsoft Cluster)
• Knowledge of HP Servers (ProLiant Blades, SAN (Storage Area Network) and ProLiant Series) and Backup Tape Unit Libraries equipment
• Knowledge of monitoring and security software for Infrastructure Equipments (SolarWinds, LANGuard, Fortress)
• Dependable with a good work ethic, teamwork and leadership skills.
• Able to adapt rapidly to changing environments.
• Strong interpersonal skills, respectful to customers and co-workers.
• Energize and enthusiasm to keep up with emerging technologies.
• Familiar with problem determination, resolution techniques and procedures.
• Ability to multi-task while establishing priorities and meeting deadlines.
• Ability to work efficiently with or without supervision.
• Ability to work in a diverse and team-oriented environment.
• Always pursuing for self-improvement.
• Microsoft Certified Professional:
• Installing, Configuring, and Administering Microsoft Windows 2000 Professional (70-210)
• Installing, Configuring, and Administering Microsoft Windows 2000 Server (70-215)
• Managing a Microsoft Windows 2000 Network Environment (70-218)