Adon N. Garza Email & Phone Number

Gaithersburg, Maryland, Us

Global Business Process Owner for Cleaning Validation. Responsibilities include providing communication updates to site process owners, managing and providing updates to the Corporate Cleaning Validation standard, harmonizing cleaning validation approach across multiple sites. This activity also encapsulates managing cross site meetings and providing guidance updates. Alignment/Harmonization of items include adoption of a corporate wide sprayball coverage testing and swab training. This role also includes ensuring cleaning validation process is in alignment with updated regulatory expectations and industry best practices such as the revision to monograph USP 1051 Cleaning Glass Apparatus monograph.Responsible for managing the site cleaning validation program and all related cleaning validation activities. These items include a quarterly review of the performance of Containment CIP and Non-containment CIP skids and parts washers along with writing the Annual Product Quality Review sections related to cleaning validation.Project lead for the implementation of the Ellabs ValSuite Pro system. This temperature mapping system includes data loggers, thermocouple systems, laptops, servers, reference standards, IRTDs, and associated control software. Developing, reviewing, approving URS, VPP, GAP IQ/OQ, RTM, and all other validation documentation and operational procedures related to the equipment. Current SME and System Administrator providing guidance and managing user access for the system.

South San Francisco, California, Us

Performed various equipment qualification activities to include development/execution of qualification testing for a-55 deg. C compartment freezer system which included a fiber optic temp. monitoring system. Other equipment qualifications included autoclaves, warm/cold rooms, HVAC systems, column chromatography systems, and COP washers (Girton and HAMO).Site Subject Matter Expert on cleaning validation. Key contact in corporate strategy and re-design of cleaning validation. Subteam lead on Visual Inspection process and member of the Corporate Cleaning Team and Forum. Instrumental in getting product cleanability scale studies performed.Worked with various departments on cleaning requirements for New Product Introductions/site transfers.Certified site instructor for LabWare LIMS, Cleaning Validation, Change Control Process (utilizing TrackWise), and Document Imaging Systems.Initial developer and primary maintenance individual of redesigned training during corporate training initiative.Primary individual responsible for Validation Documentation Vault, to include document inventory scheduling, document imaging program activities.Key contact during regulatory inspections for document retrieval, cleaning validation, equipment qualification, and departmental training defense. Validation contractor training program complimented by FDA Inspector Thomas Arista as “Best program I have seen for contractors in the industry.” In addition, coordinated and ran daily departmental inspection meetings.Key departmental contact in the development of user requirements for the new LabWare LIMS.Site reviewer and Subject Matter Expert for various Corporate Quality Standards (QSs), Genentech Good Engineering Practices (GEPs) and PDA Technical Report “Points to Consider for Biotechnology Cleaning Validation”.Managed the risk management, commissioning, and qualification activities related to a building reconfiguration for relocating the site weigh and dispense operations.

Eli Lilly & Co. – Indianapolis, INPerformed system classification, component classification, and design reviews/qualifications for the construction of a pharmaceutical warehouse, which included purified water, HVAC, building computerized control (Johnson Metasys), boiler, refrigeration, and chiller systems.Reviewed training plans, project plans, and other documentation to ensure compliance with cGMPs and company policies/procedures.

Abbott Park, Illinois, Us

Ensured the qualification of new and existing utility systems to include purified water systems (distillation and reverse osmosis systems) and compressed gas systems (both bottled gas manifold and house systems). Authored and maintained the Utilities Section of the Divisional Qualification Master Plan for the site.Planned and managed site divisional qualification activities relating to utilities.Directly supervised 5 employees in qualification activities and managed 26 other employees indirectly when supervisor was out of office.Worked with engineering, quality, and other groups to ensure current validation/qualification requirements were met in accordance with FDA guidelines.Authored IQ/OQ/PQ protocols for compressed gas, water, and other systems. Water system qualifications included PLC control tests for water systems based on RSLogix and Rockwell AI programming.Created decommissioning documentation for water, compressed gas, and other utility systems.Coordinated revisions to current applicable operating procedures using document management system (DMS) software.Standardized/Created/Updated protocol templates for change control/re-qualification. Aided in drafting and revising Corporate Policy and Divisional Procedures on General Validation, Facility Qualification, and Utilities Qualification.Member of the ADD Process Utility Board (PUB), the ADD Process Utility Task Force, and the Corporate Utility Qualification Subteam.Reviewed and approved numerous qualification protocols and reports.Managed a $7M project relating to plant steam quality.

Abbott Park, Illinois, Us

Audited Test Method and Process Validation (TMV and PV) protocols and reports. Test Method Validation packages included Nuclear Magnetic Resonance Testing, Abbott Instrumentation (AxSYM, IMx, TDx/TDxFLx platforms), Gas Chromotography, High Performance Liquid Chromotography (HPLC), and Total Organic Carbon (TOC) testing. Process Validation packages included specific diagnostic assay manufacturing processes for TDM products, and common process packages for items such as mixing, lypholization, and diafiltration.Lead a pilot group of 15 within TDM Remediation Module on Test Method Validation which included instruction on fundamental validation concepts such as validation lifecycle, design of experiments (DOE), general documentation practices, and data gathering.Performed 10 Test Method Validations for TDx/TDxFLx and AxSYM instrument platforms for TDM products.Authored 5 Product Validation Master Plans (PVMPs) and reviewed and approved over 80 PVMPs for TDM products.Instructed other remediation modules on Validation Master Planning via meetings and seminars.Conceptualized and directed implementation of divisional approach for Test Method Validations for TDx/TDxFLx, AxSYM, and IMx platforms.Managed the day-to-day operations of the 35 individuals within the Therapeutic Drug Monitoring Validation Master Plan Group.Coordinated deletion of obsolete codes/documents between Lake County and Abbott Diagnostics International business teams.Developed change control documentation for Product Validation Master Plans.Generated and maintained a master TMV/PV list for TDM products.

Searle – Skokie, ILDeveloped and executed change control documentation for various utility systems and equipmentAuthored standard operating procedures for daily activities, such as water sampling and alarm response procedures for a pilot plant facility.Executed and documented installation, operation, and performance protocols for utility systems and qualifications for new and renovated facilities to include building monitoring controls for temperature, humidity, and differential pressure used in pilot plant manufacturing areas. Wyeth – Ayerst – Lederle – Carolina, Puerto RicoReviewed data for WFI system installation, operation, performance, and water quality.Authored final technical reports for CDI, RO equipment and WFI system installation, operation, and performance.Monsanto MSE-Newstead – St. Louis, MOExecuted and documented installation, operation, and performance protocols for utility systems and qualifications for new and renovated facilities to include building monitoring and controls systems used in animal research, pilot plant, and manufacturing areas.Prepared commissioning documentation for York Chillers, electrical system upgrades, cooling tower replacement, an emergency generator system, and an underground storage tank at an animal research facility.Verified/analyzed data collected for WFI and PW (USP) systems for manufacturing and testing areas.Abbott Chemical and Agricultural Products Division – North Chicago, ILPerformed surface area calculations for cleaning validation package development for Clean-In-Place (CIP) systems, collected and analyzed data during execution of those packages.Adventis-Berinig (formerly Centeon L.L.C.)Lead company representative/site manager with a key focus on building client relations.Supervised 3 direct reports working on various utility qualification projects focusing mainly on WFI and PW systems.Managed budgets and timelines for company awarded projects on site.

Measured Mononine (blood coagulation factor IX) for moisture content using a FT-NIR spectroscopy scanning process.Performed lot reconciliation following cGMP and good documentation practices.Completed validation documentation for moisture content measuring scanning process using FT-NIR spectroscopy.

Bachelor Of Science, Chemistry

Associate Of Science (A.S.), General Sciences