SUMMARY:

• CSV Process Automation and Control; FactoryTalk ViewME; Single Board Systems; Data Management System; Enterprise Resource Planning (ERP)CSV Control Logix 5000 PLC, RSLogix/RSView 5000 and RS/Batch Web Control; DeltaV validation (Batch Historian; Alarm Rationalization); AS/400; RPG/400; Query/400; CL/400; SQL/400 Ethernet, Frame Relay LAN/WAN, DSL, TCP/IP, VPN, Cisco Routers 3600 & 800 series, 3Com Hub’s CSU/DSU; VMWare; JavaDB2; SQL Server 2005 Reporting Services (SSIS/SSRS/Relational Data Modeling); SQL - Server; SAP MM / WM; 2000/Management Studio; RPG IV; Oracle 10g; Access 2010; BASIC5;
• MS Project; Versa AT2, Versa 200 and Versa 8 Imaging Scan.
• ISO 9001;21 CFR Part 11- cGMP; ANNEX11; GAMP; Traceability Matrix; VP, UR, FD, IQ, OQ, Test Plan; VSR; Trackwise; SOPs; SDLC; AGILE; S88
• Victor is a Computer Engineer with fifteen years’ experience in Software Development, Computer System Validation (CSV), Software Quality Assurance (SQA) and Information Systems Management in a GMP-Regulated Environment and IT / Network Infrastructure. He is also skilled and adept in IT and Automation Infrastructure qualification. Has experience in the development, integration, and qualification of ERP systems, MES, and PCS. He has designed, integrated and validated electronic batch record, weigh and dispense, recipe management, work in progress, and automated process order MES functionality. Additionally, he is customer oriented and seeks to resolve problems and provide efficient and effective solutions.
• Building Quality Assurance (QA) / Automation infrastructure for networking products/software, managing QA functional/systems verification, filed trials/customer support/escalation teams within the computer department. Victor is effective in and supervised M.I.S., staff and end-users with a track record for obtaining user support with a low critical problem factor. He is people oriented in the process of seeking solutions for problems, resulting in higher productivity and better job satisfaction.

PROFESSIONAL EXPERIENCE:

Confidential, Atlanta, GA

Computer Engineer - SAP Integration Support (MM / WM)

Responsibilities:

• Responsible review and provide comments on submitted CSV deliverables, ensure validation efforts are executed to plan and properly documented in the appropriate validation documents, are complete, accurate, authored per established standard operating procedures and adequate for the intended use and in alignment with applicable FDA/EU and ISO regulations, GMP/nGMP; GAMP5 compliance; 21 CFR Part 820 and 21 CFR Part11; SDLC / AGILE; CAPA.
• Generated / Review writing validation protocols; VMP, URS, FS/DS IOQ, PQ; SOPs / Traceability Matrix and Work Instructions which maintain with IT GxP compliance.
• Plan, conduct and report routine GxP audits including third party audits.
• Lead the execution of the audit activities maid associate to GMP and appropriate applicable regulatory requirements. Enable team (SME / Vendor) team to be inspection ready and support a culture of sustainable FDA compliance.

Confidential

Computer Engineer

Responsibilities:

• Responsible improving, and maintaining a high level of, data quality / data integrity for spreadsheets used GMP / nGMP.
• Data Analysis calculation and interpretation of data graph for spreadsheet within the GxP regulations, requirements and GAMP 5 compliance.
• Generated writing report for validation protocols; Test Scripts; OQ; SOPs and Work Instructions.
• Review spreadsheets standard operating procedures for laboratory, packaging and manufacturing.
• Generated / Executed test procedures to validate new or previously spreadsheets, include deviation/discrepancy resolution (Change control).

Confidential

Validation Engineer

Responsibilities:

• Responsible for the Development/Execution of validation protocols, Commissioning Master Plan (CMP), Installation Commissioning (IC) and Operational Commissioning (OC); Validated System CIP Base Vessel / Storage and Distribution, VMWare Window Host, Setting up Virtual PCs including Workstation 5/6.
• Provide support in Turn Over Packages (TOP) reviews and execution of RV’s and IV’s for the Tank Vessels and the corresponding components and operating mechanism as per the design requirements meeting the acceptance criteria within the Plant Project. Responsible of daily Field Inspections at construction site to ensure project complies with Baxalta specifications / regulations.

Confidential

Validation Engineer

Responsibilities:

• Responsible for the Development/Execution of validation protocols, Commissioning Master Plan (CMP), Installation Commissioning (IC) and Operational Commissioning (OC).
• Provide support in Turn over packages (TOP) reviews and execution of RV’s and IV’s for the New Emergency Generators, Switchgears, Breakers and the corresponding components and operating mechanism as per the design requirements meeting the acceptance criteria within the Plant Project.

Confidential, Boston, MA

Alarm Management Computer System Engineer

Responsibilities:

• Completed all current and required short term Quality Systems necessary for remediation of alarm systems at all Confidential Massachusetts facilities.
• Piloted the completion of alarm rationalization prototype and new Alarm Management Program procedure.
• Created spreadsheets for the alarm rationalization database tool within set points, control modules, interlocks, frequencies, alarm ranges, continuous alarms, sequenced enabled alarm settings, alarm type, delays, priority and other information; Developed transition plan to describe movement from current state of alarm management to future estate including:
• Created documentation structure after meeting with SMEs’ (Standards spreadsheets, etc.); Directed/set boundaries for application of new alarm management program to new alarm systems in development or initiated during the transition period; Developed project schedule to monitor project progress.
• Developed gap assessment and remediation plan for all alarm systems at Confidential Massachusetts sites; Developed alarm management program supporting procedures as outlined in the transition plan.
• Developed and revised alarm management program documents ensuring alignment of the documents with the related evolution of the Manufacturing System Lifecycle program documents.

Confidential

Responsibilities:

• Met industry and customer requirements within in a team environment and independently to meet defined objectives based on an established timeline and deliver project work in a manner that was consistent with the company’s values.
• Developed Verification/Qualification deliverables including Requirements Documents, Functional and Design Specifications, Test Protocols, and Summary Reports.
• Executed Test Protocols, including identification and resolution of non-conformances/deviations using PIDs and other information as guides
• Tracked and managed change control activities for multiple deviations.

Confidential, San Juan, PR

MSBI SSIS System Analysis / Tester

Responsibilities:

• Created traces using SQL server profiler and modify those queries as a part of Performance Tuning operations; Validating Data / Monitoring and debugging of daily job failures; test scripts; IQ.
• Successfully migrated data between different heterogeneous sources such as flat file, Excel and SQL Server 2008 using SSIS.
• Created and when required, modified already existing stored procedures, triggers, views, indexes; data validation security purposes, implemented rules, defaults, and user defined data types; load data from various sources like OLEDB, flat files to SQL Server database Using SSIS Packages and created data mappings to load the data from source to destination.

Environment: MS SQL Server 2005/2008, SSIS, OLAP, SSRS, MS Visual Studio 2005, Windows.

Confidential, San Juan, PR

SQA Analysts Tester Automation

Responsibilities:

• Created standard test environments, tests plan, and test scripts. Conducted acceptance testing of new or modified applications and systems and assist with modification of testing systems or tools.
• Systems Analysis Documents, various Q/A walkthroughs, project estimates and project reporting/tracking. Provided periodic status reports on project progress to QA and Business leadership (Microsoft BI) teams using standard JIRA and Clarity PPM tool set for project portfolio management.
• Responded to system failure and performance events, taking appropriate measures to reduce system downtime and eliminate recurrence of the problem. s: Defined the activities performed to provide assurance that the software-related items delivered to the customer conform to the established and contracted technical requirements and agreement. Also described how the project would be audited to ensure that the policies, standards, practices, procedures, and processes applicable to the project are followed.

Confidential, San Juan, PR

POS System Analyst and Project Manager

Responsibilities:

• Created Models/Reports packages on Framework Manager / Cognos8 connection with Oracle 10g, apply security Framework Manager Packages and Query subjects. Supervised project team members, external vendors, including IT consultants to engage and maintain initiative technology task of the project within the budget and Business Life Cycle. Led the planning and implementation POS Cycle project installations, Risk Management and Project Closure (Signoff).
• Performed modeling testing scope (Test and Development environments using Cognos Impromptu) based on findings through use-case scenarios, workflow diagrams, and data models; created the Functional Specifications, Architecture System Interface Design, Software Verification and Validation Plan.
• Developed test requirements and plan to validate application changes supporting business logic cycle; Created technical documentation for the Cognos8 reports based on the Business Cycle Requirements which, provide a high degree of assurance that the computerized system setup perform according to the client specification.

Environment: Oracle 10g; Flat Files; DB2; SQL Server 2005; .NET/Vbasic5; Informatica 8; Erwin.

Confidential

SQA System Analysts “MM” SAP Module Consultant

Responsibilities:

• Analyzed and challenged the modification done to the Batch Number or Lot Number field before the validation or test scripts’ to ensure proper requirements has being follow. It discovered that the field was able to be duplicated with the creation process of the Purchase, Process Orders, Good Receipts, Return Delivery and other SAP Transaction Codes that has relation with the modification.

Environment: .NET, SQL 2000 Server, Windows 2003 SERVERS & PCs’; SQL Trace, ABAP Query and BC ABAP-Dictionary.

Confidential

CSV/System Analysts Human Resource Application/BPCS Consultant

Responsibilities:

• Developed and modified Informatica8 Source/Source Qualifier/Targets, Transformations, Mappings, Lookups, Reusable Components, Sessions and Work Flow as per the design documents and business requirements.
• Conducted requirement gathering, Data Analysis, Coding, Code Review, Integration/Testing, Implementation, Production Support, Project Management, Weekly/Monthly Status reports and Acceptance Stage. s: Identification of software configuration items, Control and implementation of change, record and report change and problem implementation status, conduct configuration audits, review and approval cycles as well as approval authority, and identify of personnel responsible for configuration management to establish an interface between modules for a better use of system.

Confidential

CSV Integration Consultant Coordinator (DVS and Viviant)

Responsibilities:

• Created SCADA System Configuration Unit Protocols after verifying the ODBC ORACLE / SQL connection on the SCU system, Alarm configuration, Inter Locks, Computer Ethernet address configuration on the Network administration and the PLC TCP/IP 10 MBit Ethernet address configuration driver.
• Created and reviewed Design Specifications, IQs and OQs for the following (Using as SAT, FAT, USR, FD, PLCs’, PIDs’); Fette 2090 WIP Tablet Press System- Lower CAM Tracks (Transition CAM-Lower Precomp. Roll); Feeder Base Pan; Scraper; Pressure Rolls & Components; Blender Room System; Allen Bradley Control 1200 Cabinet including the WIP Center; Software Configuration and hardware configuration (HMI), and diversified Computer Validation 21CFR parts 210 and 211. s: Establish Software Requirements Specification (SRS); Software Design Description (SDD); Software Verification and Validation Plan (SVVP); Software Verification and Validation Report (SVVR); User Documentation; Software Configuration Management Plan (SCMP).

Confidential

SQA System Interface Integration Project Leader

Responsibilities:

• Created, maintained, and support execution decommission protocols (Configuration Management Plan; Validation Plan; Technical Installation Plan; Test/Case Plan; System Requirements; Design & Unit Specification; Source Programming Standards; Source Code Review Report; Support Quality Plan; Computer and server; Decommission In-house Data Centers.
• Environment: DB2, Oracle 9i, DTS in SQL Server 2005 and Erwin; AS/400; RPG/400; CL/400; TrackWise Quality Management. s- Design and review the Software Requirements; System Architecture; Technical Design; Software Verification and Validation Plan; Software Configuration Management Plan.

Confidential

Performed Software Quality Assurance

Responsibilities:

• Created, reviewed and supervised the documentation (IQ/OQ protocols) for the Clean Utilities; Purified Water Storage (Block Valve HV-6090, 6203) and Distribution System (WFI; Seed Fermentor; Microfiltration; Cell Paste; Cuno Filter; and Purified Bulk.
• Hardware/Software used for documentation support were the PLC/Controllers (CL/1756 System and Digital Wiring System and MicroLogix 1500; RSView; RSBatch), using PIDs’, PLC, Software Detailed Design Specification ‘SDDS’, Functional Requirement Specifications ‘FRS’, as d. Support Instrumentation Troubleshooting, by generating data analysis reports and final report preparation for the computer-related system; Provided technical assistance to inquiries regarding errors, problems, or questions with program.

Environment: RSView; RSBatch; SCADA; AS/400; SQL Server; CL/1756 System and Digital Wiring System.

Confidential

SQA System Interface Integration Project Leader

Responsibilities:

• Ensured all protocols’ (UR/FS/SATs’; IQs’; and OQs’ business process documentation is written, reviewed and validated by the cGMP, QA and myself. Coordinated and followed all integration tests to ensure proper MAPS (SAP replacement) data flow is achieved and match with the business cycle within the others applications (Computron for Finance; DataStream for ‘ERP’ and Manujistics for Planning).

Environment: DB2, Oracle 9i, DTS in SQL Server 2005 and Erwin; AS/400; RPG/III-IV; CL/400; SQL/400; MS Project; Query/400.

Confidential

MIS Manager/Project Leader

Responsibilities:

• Designed, modified, tested and supported computer programs/systems such as: JD Edwards 5.1, Hotel Information System in an AS/400 platform (RPGIV / Query/400), Squirrel P.O.S., and (VBasic/Access 2000).
• Researched and developed new process, procedures and computer systems that improves daily hotel operations, and prepared the department budget.
• Identification of software configuration items, Control and implementation of change, record and report change and problem implementation status, conduct configuration audits, review and approval cycles as well as approval authority, and identify of personnel responsible for configuration management to establish an interface between modules for a better use of system.