Luis Diaz Email & Phone Number

Juncos, Puerto Rico

Direct technical validation engineering support of process and equipment upgrades, replacements, and modifications in the laboratory or manufacturing environment. Troubleshoot systemic validation issues. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures as follow:• Design and execute experimental studies for the development of Sterilization and Decontamination manufacturing processes: o Isolator & MTI System, Formulation Transfer Line, Vial Isolator• Developed, organized, analyzed and present interpretation of results for operational issues or validation engineering projects of significant scope and complexity using LIMS, Kaye Validator & Data loggers, PI Data sheet tool, DacS tool and Picarro System.• Developed requirements and recommendations with manufacturing, process development, facilities and other areas in for highly complex process, system/facility modifications for Process Validation.• Apply advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects for Periodic Monitoring’s and Periodic Review’s validation exercise. • Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.• Apply knowledge of validation engineering principles and practices in area of expertise to broad variety of assignments in related fields. Computer System Validation, Technical Writing & Equipment Qualification

Gurabo, Puerto Rico

CSV report preparation, execution and engineering support for Packaging Line Serialization System (Systech Advisor), Equipment’s and Inspection Vision Systems (Systech Sentri and Scanware (“Spectra Inspection System” and “Signum Inspection System”). Mostly PLC Phoenix Contact, B&R and Schneider, and software for manufacturing area for Pharma and Medical Device for packaging area. Performance in the area of computer system validation (CSV) and Qualification (C&Q) for packaging equipment, validate the new Esketamine Packaging line system and software; Systech Advisor and Sentri Inspection for Serialization, Automated Nasal Spray Device Assembly, Device Label Systech Inspection system, Blister Inspection (Signum and Scanware Systems), HAPA Printer, MGS Outsert Inspection system, Mediseal Thermoformer and Cartoner/Bib-bob module, Scanware Inspection System (Device Presence, Foil Printing, Cartons and Inserts), OCS Print and Check with Checkweigher, OCS Tamper Evident, Pester (Case Packer and Palletizer Machine) and Cyberlogic/Easy Label for its Intended purpose in compliance with Janssen J&J Gurabo requirements and packaging specifications. The validation / qualification deliverables and related activities performed are:• Risk Assessment• SOP preparation and revision • User Requirement Specification (URS) revision• Functional Design Specification (FDS) revision• Development execution and CSV report preparation of the qualification/validation package IQ/OQ/PQ• Revision System Design Specification (SDS)• Traceability’s Matrix (TM)• Validation Finals Reports (FR)• Discrepancies Memo (DR)

Dorado, Puerto Rico

Report preparation, execution and engineering support for Packaging Line Serialization System (Systech Advisor), Equipment’s and Inspection Systems (Cognex). Mostly PLC Allen Bradly and software for packaging area. Performance in the area of computer system validation (CSV) and Qualification (C&Q) for packaging equipment, validate the new system and software Advisor Inspection for Serialization, Sentri Kiosk clients and Guardian server for its Intended purpose in compliance with PuraCap Caribe requirements and packaging specifications. The validation / qualification deliverables and related activities performed are:• SOP preparation and revision • User Requirement Specification (URS) revision• Functional Design Specification (FDS) revision• Development execution and CSV report preparation of the qualification/validation package IQ/OQ/PQ• Revision System Design Specification (SDS)• Validation Finals Reports (FR)

Arecibo, Puerto Rico

Validation report preparation and execution for installations and modifications of the KORSCH XL400 tablet press and ancillary equipment Auto Tester 4 Standard (AT4) Tablet Tester & De-duster / Metal Detector KD7015-THS/PH21N to be used in the Manufacturing Area Facilities at AVARA Pharmaceuticals Services, Arecibo Site. Performance in the area of Commissioning and Qualification (C&Q).• SOP revision; Risk Based Project Plan (RBP• Development execution and report preparation of the qualification/validation package IQ/OQ, SAT revision

Manatí

• Proving, challenging, and implementing Validation and Quality Assurance strategies through risk-based evaluating of existing environments, uncovering CSV and cGMP’s 21 CFR Part 11 compliance gaps and optimal remediation strategies.• Reviewing CSV deliverables Validation Project Plan, URS, TM, IQ, OQ, PQ, Vendor Reports, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Reports for Data Integrity compliance.• Reviewed and followed SOPs to help the business process in line with FDA, EMA regulations.• Organized and attended meeting to discuss the status of the projects.• Work FMEA exercise for laboratory equipment and Freeze -Thaw equipment.

Manatí

Validation report preparation and execution for installations and modifications of the Unidirectional Flow Module (UFM) System and Parenteral Vial Area (PVA) Cell 2 New Manufacturing Suite Project. Performance in the area of Commissioning and Qualification (C&Q). Revision for the validation documents of the new system and facility for its Intended purpose in compliance with Bristol-Myers Squibb requirements and process specifications. The validation / qualification deliverables and related activities performed are: IQ/OQ protocol revision. • Validation Finals Reports (FR)• Interim Report• User Requirement Specification (URS) revision• Design Specification Document (DSD) revision

Barceloneta

CSV report preparation, execution and engineering support for Extrusion System Equipment, HVAC System, CIP System and Control Systems, hardware & software. Mostly PLC Allen Bradly and Siemens (S7-300 &S-IM151-8) and software for manufacturing area. Performance in the area of computer system validation (CSV). Validate the new system and software for Information Virtualized OS server, OS clients and Batch server for its Intended purpose in compliance with ABBVIE ltd. requirements and process specifications. The validation / qualification deliverables and related activities performed are:• SOP revision; Risk Based Project Plan (RBP), • User Requirement Specification (URS)• Functional Design Specification (FDS) revision• Factories Acceptance Test (FAT) in Germany• Revision System Design Specification (SDS)• Development execution and CSV report preparation of the qualification/validation package IQ/OQ, Comm., SAT revision

Irvine Ca

Development execution and CSV report preparation for Control systems, hardware & software. Mostly PLC & DCS Siemens (S7 & WINCC or PCS7) and WERUM (MES) software for manufacturing area for Pharma and Medical Device. Performance in the area of computer system validation (CSV). Validate the software upgrade and migration for Information Virtualized OS server, OS clients, Batch server and Integration Layer for its Intended purpose in compliance With B.Braun Medical Inc. requirements, IT area and process specifications. The validation / qualification deliverables and related activities is performed:• SOP revision; Risk Based Project Plan (RBP), • User Requirement Specification (URS), Functional Specification• Revision System Design Specification (SDS)• Development execution and CSV report preparation of the qualification/validation package IQ/OQ, SAT revision

Manatí, Pr

Development and implementation for qualification of the LAN system, servers, switches, firewall, cables and wirings in the new facility of Romark Global Pharma L.L.C., Manatí site and validating the corporate network including, Tampa, New Jersey, Manatí and Belgium. Assist in the document preparation and strategies consultancy and in the development of validation plans. Ensure the quality, quantity, and integrity of assigned tasks. Responsibilities included:• Participation in exercises FMEA identifying areas susceptible to system failures, all as part of the exercise of Risk Assessments.• Management and coordination of telecommunication service providers.• Preparation of reports for the qualification/validation package IQ/OQ Commissioning and Operational document for LAN network.• Development User Requirement Specification (URS).• Development System Design Specification (SDS).

Guayama, Pr, Puerto Rico

Performance in the area of computer system validation (CSV). Validate the machines ADVIL SUGAR COATING CONTROL SYSTEM UPGRADE and CAPSULE BANDER MACHINE SYSTEM NEXIUM AREA for its Intended purpose in compliance With Pfizer Consumer Healthcare (PCH) requirements and process specifications. The validation / qualification deliverables and related activities was performed; Risk Based Project Plan (RBP), User Requirement Specification (URS), Design Specification Document (DSD).

Cataño, Pr

Responsibilities include accountability for all aspects of project execution, including layout engineering, OEM/contractor management, equipment procurement, schedule management, electrical design, electrical programming including SIEMENS Systems, installation support, documentation, customer interface, installation management, project management, Control System Administration, Troubleshooting, Investigations, Commissioning and Validation.• Control systems development, hardware & software. Mostly PLC & DCS Siemens (S7 & WINCC or PCS7). Construction Supervision and startup.• Programming devices like HMIs, Instrumentations, Servo Drivers, and others within packaging line equipment. Develop project documentation including Operational Manuals. Provide support to all Manufacture and Process Areas.

Las Piedras, Pr

Performing the coordination of the equipment installation of the Environmental Monitoring System (EMS) and validation assignments of computer systems across the Consent Decree, within approved validation plan, procedures and schedules. Developing and executing validation protocols and procedures. Planning and schedule validation efforts associated with assigned projects. Developing and reviewing validation documents, and reports. Developing or assisting in the development of consulting documents and strategies. Assisting in the development of Validation plans. Assuring quality, quantity, and completeness of the assigned tasks. Performing other validation related work as require. Provided support to the project and the CSV Team, with the following activities:• Development the coordination of equipment installations, coordinate the contractors, electrical trouble shooting, drawing interpretation, inspection, consulting and supervise the activities related to management of the project.• Development execution and CSV report preparation of the qualification/validation package for the Process Automation System which handled and monitored the; Temperature and Humidity Transmitter (THT) and Differential Pressure Transmitter (DPT) in the areas - Siemens Automation

Cost estimator and project manager. Responsible of capital, material and human resources management for electrical projects. Ensure material availability; provide technical expertise, quality, safety, and cost control. Working in project like San Juan (ZSU) CERAP Ops Bldg. Seismic Upgrade and Administrations Building Demolition at the Federal Aviation Administration (FAA) Facilities.

Responsible for collecting information of PLC systems where documentation prepared for delivery to customers. Also works as implementing new PLC systems and preparing proposals and estimates to be made. Training in different programs for monitoring equipment, quality testing and others. Working well in industries such as Pepsi Puerto Rico, Rafael J. Nido, dairy Tres Monjitas, Pfizer Puerto Rico and others.

Physical Plant Facility design for telecommunication system, cooper and fiber optic.

Industrial electrical work as high voltage wiring combined, switch panel, fire alarms and general lighting such as lamps and power outlets. Interpretation of the project drawings and prepare the documentation at the end of the day.

San Juan, Pr

Central Thermoelectric Palo Seco: Work in the area of combinations specifically where all the relays panels and cabinets of manufacture (Foxboro and Ovation) are located. Assisted Provide effectively Electricians and Engineers. With experience in cable combination in; Instrumentation Cables , Control Cables, Power Cables, Cat’5 Ethernet Cables, Fiber Optic Patch Cords, Belden RS232 RS485, DCS Cabinets (Foxboro), Sync Panels, Relay Panels, Training in the techniques of application and installation in MV(5-35 kV) Cold Applied Terminations and Marks VI (GE).San Juan Electrical Plant Facility: Completed efficiently and effectively the due dates obtaining equipments working, signal panels and power combinations. Building service, switchgear, power conditioning equipment and general lighting. Provide effective support and assistance to the Electrician. With experience in cable combination in; Instrumentation Cables , Control Cables, Power Cables, Cat’5 Ethernet Cables, Fiber Optic Patch Cords, Belden RS232 RS485, DCS Cabinets (Ovation), Sync Panels, Relay Panels and Marks VI (Ovation).