Senior Consultant

Wilfredo H. Santiago Torres

PO Box ***, Peñuelas PR 00624

********@*****.*** 787-***-**** 787-***-****

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Senior Consultant

Team oriented quality professional with over nine (9) years of experience within the Pharmaceutical, Medical Device, API and Biotechnology industries with notable success leading and supervising multiple resources, projects and tasks.

Support in the design and implementation of Receiving Inspection, Manufacturing, Utilities, Facilities and Laboratory process / equipment.

Supervise and provide support to resources on multiple projects and tasks.

Experience in the qualification of Computerized HVAC Control Systems.

Experience qualifying sterilization and preconditioning chambers.

Experience in Computer System Development Life Cycle documents preparation and execution (Change Control Requests, User Requirements, Design / Functional Specifications, Validation Strategies, Validation Plans, Traceability Matrices, Code Reviews, IQ, OQ, Final Compliance Reports).

Experience in 21 CFR Part 11 (Electronic Records/Signatures).

Experience in 21 CFR Part 820 (Quality Systems Regulations/GxP)

Experience in 21 CFR Part 210 and 211 (Pharmaceutical Industry)

Outstanding leadership abilities; able to coordinate and direct phases of project based efforts while supervising, motivating and leading project teams.

Experience generating and updating company procedures, franchise documents and policies by using “voice-of-customer (VOC)” and issues identified during normal operations or system/process qualification activities.

Experience developing and performing formal presentations/trainings for the Site Management Team, Manufacturing personnel, Utilities/Facilities personnel and contractors.

Core Competencies

• Project Management

• Customized Software Development and Implementation

• Non-Conformance Investigations

• Regulatory Adherence

• Safety and Environmental Assessments

• Data Analysis and Reporting

• Equipment Qualification

• Technical Writing

• Computer and Peripheral Configuration

• Database Administration

• Document Reviewing • QSR

• Risk Assessments

• Fully Bilingual

• GAMP 4

• CGMP

• Environmental Monitoring

• Temperature Mapping Studies

• Deviation Incident Reports

• Computer Validation (including Part 11 requirements)

• Commissioning of Facilities

• Factory Acceptance Tests (FAT)

• Facility Qualifications

Technical Proficiencies

Programming

Languages: Visual C++, Visual Basic, COBOL, RPG, Microsoft Access, Visual Fox Pro, Pascal, SQL.

Tools: Minitab, Maximo, LIM’s, Empower, Microsoft Project, Visio, Quattro Pro, Microsoft PowerPoint, Microsoft Word, Microsoft Excel, AutoCAD, Lotus 123, Peach Tree, Kaye Validator 2000, Temptale Manager, Norton Ghost.

Professional Experience

Cordis LLC, San Germán PR (a Johnson and Johnson Company) 2006 - Present

SQC Engineer

I have been a member of the SQC (Software Quality Compliance) Department for over 4 years. Responsibilities include review and approval of Change Requests (CR), Risk Assessments (RA), Validation Strategies (VSD), User Requirements Specifications (URS), System Requirements Specifications (SRS), Technical System Designs (TSD), Equipment IQ/OQ Protocols, Software Installation Protocols, System Validation Protocols, Traceability Matrices (TM), Performance Qualification Protocols (PQ), Failure Investigation Reports (FIR), Deviation Incident Reports (DIR), Quality Non-Conformances (QNC) and Summary Reports. Experience includes reviewing qualification deliverables for computerized systems used in the QA/QC Laboratories, Manufacturing/Operations Dpt., Business (administration) Dpt., Materials/Planning Dpt., Metrology Dpt., Engineering Dpt., Receiving Inspection Dpt. and Facilities Dpt. As an SQC Engineer, assure that systems are developed, validated and maintained in adherence to regulatory requirements and Cordis and J&J Corporate standards.

Key Contributions:

• Current roles and responsibilities include participation in the design phase of QSR/GxP Base Business and production systems such as MES 1.3, MES Core, PLC’s, HMI’s, manufacturing spraycarts, as well as all the supporting equipment and instrumentation.

• Guidance and support in current system enhancements / optimization projects based on established corporate standards and methodologies.

• SQC support and guidance in the generation of CSV Deliverables for manufacturing, lab and base-business systems.

• Assigned to provide support in the qualification and implementation of LIMS, Empower, HPLC’s, UPLC’s, FTIR’s, Heatblocks, Environmental Chambers, Incubators, Dew Point Monitors, Ovens, Finn Aqua Autoclaves, Isolators, Scales and other laboratory equipment / system validations.

• Was assigned the Compliance Team Leader role for the implementation of QA Receiving Inspection equipment and Test Methods transferred from Miami to San Germán.

• Daily tasks include providing support and guidance on the closure of important issues/non-conformances and investigations.

• Provided guidance and support on Laboratory, NPD and IT/ Network infrastructure projects.

• Assigned to provide support in the implementation of World Wide laboratory and manufacturing systems such as LIMS and MES.

Professional Experience (cont.)

Cordis LLC, San Germán PR (a Johnson and Johnson Company) 2003 - 2006

Senior Validation Specialist

• Provided service, as a consultant, to the Final Release Department; tasks included the generation, review and update of manufacturing documentation (batch records, products specifications and standard operating procedures). Documentation was verified to assure compliance with FDA regulations, Cordis/J&J Corporate Standards and site specific procedures. Provided support in the development of a batch record filing process on plant startup. Evaluated, proposed and enforced the implementation of changes to process, SOP’s and equipment for manufacturing operations enhancements.

• Project Manager responsible for the implementation of complex computerized systems such as Uninterrupted Power Supply (UPS) Systems, Heating Ventilating and Air Conditioning (HVAC) Control Systems and Building Management Systems (BMS).

• Managed the qualification and implementation of a Process Water System that provided USP compliant water used for manufacturing operations.

• Provided full support to the Cordis QA Department, on a three (3) year assignment, in the development, qualification and administration of a corporate worldwide web-based database application containing important lot manufacturing, laboratory, sterilization and shipping data.

• Managed resources working on the development and execution of IQ/OQ and PQ protocols for new areas built for process improvements including the qualification of explosion proof areas and equipment.

• Provided guidance and support in a site expansion project where four (4) new manufacturing modules were constructed to meet product demand. Activities included generation and execution of Facilities, Utilities and Equipment protocols and procedures.

Key Contributions:

• Performed batch record auditing.

• Performed qualification of critical QA Micro-Lab equipment and Test Methods transferred from other sites.

• Leader of a group of 4 professionals providing Product Quality Data to the Worldwide Cordis organization. Led the team to a 50% Database Data Entry Lead time reduction.

• Instrumental in developing and implementing Standard Operating Procedures, Trainings and Action Plans.

• Provided support in the resolution of CAPA’s.

• Performed a Facility and Utility Qualification for a new manufacturing process improvement area.

• Provided support to QA laboratory personnel performing viable, non-viable air and surface monitoring simulating “static” and “dynamic” conditions.

• Led and supervised computer system implementation projects.

Professional Experience (cont.)

OMJ, San Germán PR (a Johnson and Johnson Company) 2002 - 2003

Validation Specialist

Provided support to the Technical Services Department and Engineering Department as required by client specifications. Responsibilities included the validation of facilities and equipments such as Incubators, Isolators, Finn Aqua Autoclaves, Automatic Inspection Machines, Gruenberg Ovens, Ethylene Oxide Sterilization Chambers, Sterilization Process, Pre-Conditioning Chambers, Freezers and Refrigerators. Assigned to support and supervise external contractors in charge of the construction and modifications of the facilities during Cordis LLC startup.

Key Contributions:

• Performed qualifications and studies to pre-conditioning and sterilization chambers at Steri-Tech Inc., Salinas PR.

• Provided support in the qualification of SCADA systems.

• Performed temperature mappings in warehouses, production and laboratory areas.

• Performed temperature studies on incubators, freezers and ovens.

• Provided support on the commissioning and qualification of eight (8) coating modules prior to Cordis LLC startup. Activities included verification of electric drawings, walkthroughs, equipment installation, equipment identification, nitrogen gas / compressed air pipe identification, room identification, SOP generation, etc.

• Provided “gowning/de-gowning” training to Cordis LLC manufacturing personnel hired for plant startup.

• Provided support in the generation of “Preventive Maintenance” procedures for cooling towers, chillers, exhaust fans, AHU’s and dehumidifiers.

OBI, Manatí PR (a Johnson and Johnson Company) 2001 - 2002

Validation Technician

Provided support in the qualification of a Honeywell Building Management System. Performed constant monitoring of room parameters (temperature, relative humidity and pressure) and was also in charge of analyzing and reporting the data in MS Excel and Minitab. Performed full validation cycles on freezers and incubators that would store biological product.

Key Contributions:

• Worked extra hours and weekends in order to meet a deadline in the qualification of a critical (– 40 C) freezer used to storage biological product.

• Was in charge of generating reports and trending charts using temperature, differential pressure and relative humidity data gathered daily.

Education

Bachelor of Science in Computer Science

Major in Information Systems

University of Puerto Rico - Ponce, PR

Trainings and Certifications

Current Good Manufacturing Practices (cGMP’s)

Good Automated Manufacturing Practices (GAMP 4)

21 CFR Parts 210/211

21 CFR Part 820

21 CFR Part 11

Kaye Validator 2000 Thermal Validation System

Computer System Validation

Technical Writing

Certified Calibration Technician

Member of the American Society for Quality (ASQ)

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