Bobby Harris

Validation specialist with strong expertise in quality assurance and regulatory compliance. Proven ability to ensure accuracy and reliability of processes and systems, with emphasis on team collaboration and adaptability to changing needs. Skilled in data analysis, process validation, and risk assessment. Known for reliability and achieving optimal results in dynamic environments.

• Collaborated with team of seven[7] in the development of the Optel Finishing Line Serialization Project. 15 systems/lines were upgraded for label serialization.

• Introduction to Computer Validation – Wake Tech Community College – 8 Hour Course Completion.
• Computer Application – Wake Tech Community College – 16 Hour Course Completion.
• Basic Concepts of Validation – Wake Tech Community College – 8 Hour Course Completion.
• Validation Documentation – Wake Tech Community College – 8 Hour Course Completion.
• Risk Based Approach to Validation – Wake Tech Community College – 16 Hour Course Completion.

• Pharmaceutical System Experience: 22 Years
• Validation Experience: 12 Years
• Validation Document Life Cycle Experience: Requirements / Specifications: User Requirement Specifications, (URS), Functional Specifications (FS), Hardware Design Specifications (HDS), Software Design Specifications (SDS), Design Qualifications(DQ) Computer Classification Assessments (CCA), Equipment Classification Assessments (ECA), Alarm Assessments. Electronic Records, Electronic Signature Documents (ERES).
• Getinge Sterilizers, Product Serialization, Temperature Mapping - Kaye/Ellab/TempTales, Automated Process Controls (APC), Computer System (Hardware/Software) Validation.
• Facility Qualification, Utility Commissioning / Qualification -Water for Injection (WFI), High Quality Steam (HQS), Nitrogen2, Carbon Dioxide CO2, plant steam, Compressed Air (OFCA) etc..., HVAC Commissioning / Qualification (Metasys / Vaisala Environmental monitoring systems), Equipment, Utility, APC, Computer, Facility Decommissioning.
• Requirements and Specifications: User Requirement/Functional Specifications (URS / URFS) for the Metasys Validation Environment (MVE) Building Management System (BMS), the Vaisala viewLinc Environmental Monitoring systems and refrigeration. Functional Specification, Design Specifications, Design Qualifications, Computer, Equipment and Alarm Assessments for Finishing line Equipment and Utility applications.
• Document Generation: Responsible for development and generation of the following validation life cycle documents: Risk assessments, validation plans, trace matrices, change controls ,deviations, Automated Process Control Functional Requirements Specification, Detailed Design Specifications, Installation Qualifications, Operational Qualifications, Performance Qualification protocols, Periodic Performance Qualifications, Periodic Reviews and Final Reports.
• Document Execution: Responsible for execution of approved protocols. Execution to include performance of testing, organizing execution protocols, assigning attachments, system drawing walkdowns and drawing redlines, interfacing with different work disciplines to ensure a quick and efficient completion of the executions.
• Technical Writing: Responsible for research, development and writing of procedures and validation life cycle documents. Responsible for Investigations and Technical investigative reports.
• Procedure writing experience: SOPs, work instructions and technical investigative reports for QA and Regulatory Affairs for product disposition. Validation Protocols, Specifications, Engineering Studies, Computer Assessments, Equipment Assessments and Alarm Assessments.
• PLC/Computer Validation: Develop and perform Programmable Logic Controller and computer qualifications using life cycle documents.
• PLC/Computer validation experience: Qualification of computer modifications for document control and product inventory control.
• AS400 Hardware and Software upgrades Validation and Migration for seven (7) Logical Partitions (LPAR) through out Hospira US sites.
• OPTEL Serialization Commissioning, Installation, Decommissioning and Labeling.
• Dabrico Visual Inspection systems PLC hardware and software Qualification
• Process Validation: Responsible for development and definition of validation parameters for autoclave operations. Define sampling plans and design experiments to establish best challenge conditions for qualification.
• Process Equipment Validation/Qualification: Autoclave/Sterilizer operations, Autoclave/Sterilizer Cycle Development and parameter testing and setting and Autoclave Commissioning and Qualification.
• Finishing Line and Systems Validation/Qualification: Optel System/PLC hardware and software integration for Finishing lines (15 total) for label serialization. Dabrico Visual Inspection system PLC hardware and software Qualification
• System Utilities / Facilities: Utility Systems PLC hardware and software Qualification Responsible for development and definition of validation parameters facilities/utilities qualifications.
• Utilities / Facilities Validation experience: Distilled water systems compressed air systems and HVAC systems.
• Instrumentation / Test Equipment / Lab Equipment: Test Equipment/Laboratory equipment Validation experience: Kaye Digistrip, Ellab Data Loggers, TempTales, TOC meters, pH meters, conductivity and spectrophotometer. Metasys and Vaisala EMS Temperature Monitoring Validation.
• Building Management Systems (BMS) / Environmental Monitoring System (EMS): Hardware and Software Installation, Operational and Performance Qualifications as well as software and hardware upgrades. Temperature monitoring and mapping.

• Hospira , Inc Rocky Mount, NC
• Fresenius Kabi Wilson, NC
• Sandoz Wilson, NC
• Pfizer, RM Rocky Mount, NC

Investigated a perceived failure in a "Koate Column Bulk" and discovered that it was not contaminated and was releasable.