Linda L. Glosser
Atlanta
Summary
Highly qualified Sr. Validation Engineer with over 20 years of experience as a Project Lead, Computer System Validation Lead, Equipment Validation, Laboratory Instrumentation Validation, and Quality Assurance Oversight. Dedicated to ensuring quality and compliance in the pharmaceutical manufacturing industry. Possessing excellent leadership skills and expertise as a Subject Matter Expert (SME) for large projects in FDA-regulated environments, specifically in computer software validation (CSV)/computer software assurance (CSA), quality oversight, and 21 CFR Part 11 initiatives. Skilled in working under remediation environments, prioritizing the timely implementation of commitments to regulatory agencies to demonstrate increased compliance with governing regulations and ensure business continuity. Actively contributing to meetings focused on developing and executing strategies to defend actions taken by companies under remediation, aiming to enhance compliance levels with established commitments.
Overview
9
9
years of professional experience
Work History
Sr. Validation Engineer, CSV SME/Quality Oversight
Cooper Surgical
01.2023 - 01.2025
- Validation Engineer for the qualification/validation for MasterControl Classic20, LIMS, and Acumtica
- Develop and maintain Computer System Validation lifecycle maintenance including validation documentation, hierarchy, management, etc
- Implement policies and procedures to validate/verify equipment, computer systems, and processes in accordance with regulatory requirements and company standards
- Coordinate, direct, and lead validation efforts; Including equipment, process, and computer system validation
- Work with Site Quality, Global Quality, Site IT, Global IT, QC Laboratory and R&D Laboratory, Manufacturing/Operational, Regulatory, Engineering, and upper Management Subject Matter Experts (SME) to support validation efforts
- Ensured documentation met quality standards, applicable regulatory compliance and company guidelines
- Developed the Validation Plan, Supplier Audit and GxP/GAMP & Initial Risk Assessments
- Developed User Requirements Specification, Functional Requirements Specification, Configuration Specification
- Developed test script for System Testing, test script for end-to-end user
- Developed and oversee execution of IQ/OQ/PQ
- Responsible for System Test/UAT Test Execution
- Reviewed & Approved post execution of IQ/OQ/PQ
- Develop Final Validation Report and Traceability Matrix
- Ensure Change Control Management was followed in accordance with company policy & procedures
Sr. Computer System Validation Engineer
Organogenesis, Inc.
04.2020 - 01.2025
- Implementation of Microsoft Dynamics 365, MODA, Infrastructure, Laboratory Instrumentation, Salesforce (CRM), SmartSolve, Infrastructure servers, FTIR, Endotoxin, UV-VIS, Particle Analyzer, GC MS, Osmometer, Conductivity Meter and pH Meter
- Involved in every phase of the life cycle gathering all the key requirements in the project from Design, Analysis, Development, Testing and Deployment
- Responsible for all phases of the software development lifecycle including design and planning, development, application reporting, unit testing, QA testing, installation, deployment and support
- Evaluate customer’s software environment and business processes
- Developed, reviewed and approved validation documentation including change control forms, validation plans, system testing/UAT test protocols, tests cases and reports and requirement traceability matrices
- Provided guidance and training to the departments and development and execution of validation plans
- Developed the Validation Plan, Supplier Audit and GxP/GAMP & Initial Risk Assessments
- Developed User Requirements Specification, Functional Requirements Specification, Configuration Specification
- Developed test script for System Testing, test script for end-to-end user
- Developed and involved in execution of IQ/OQ/PQ
- Responsible for System Test/UAT Test Execution
- Reviewed and approved System Testing and User Acceptance Testing Test Scripts
- Reviewed & Approved post execution of IQ/OQ/PQ
- Developed Final Validation Report and Traceability Matrix
- Ensure Change Control Management was followed in accordance with company policy & procedures
Sr. Validation Engineer, Quality Oversight (CSV)
Seres Therapeutics
04.2022 - 05.2023
- Approved system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is reported to support validation activities
- Implementation of Blue Mountain RAM (BMRAM), LIMS and QC Laboratory Instruments
- Develop and maintain CS validation lifecycle maintenance including validation documentation, hierarchy, management, etc
- Implement policies and procedures to validate/verify equipment, computer systems, and processes in accordance with regulatory requirements and company standards
- Coordinate, direct, and lead validation efforts; Including equipment, process, and computer system validation
- Effectively manage and assign resources to address priority projects, meet schedules, maximize productivity, reduce costs, and increase efficiencies
- Work with Site Quality, Global Quality, Site IT, Global IT, QC Laboratory and R&D Laboratory, Manufacturing/Operational, Regulatory, Engineering, and upper Management Subject Matter Experts (SME) to support an FDA agency audit
- Provide validation training to engineers, manufacturing/operations, laboratory, or other staff on validation protocols and standard operating procedures
- Provide regular reports to management
- Coordinate and participate in the development, testing, and implementation of interim and long-term processes and technology solutions including software testing and system level testing on new and legacy systems
- Documentation and closure of deviations generated during qualification activities execution
- Performed assessment for Manufacturing equipment, Laboratory, and ERP systems
- Generate, execute, review, and complete validation documentation required (Traceability Matrix, URS, IQ/OQ/PQ protocols, and summary reports)
- Write, revise, and review Assessments related to the Data Integrity, Qualification/ Validation of all critical components and systems
- Facilitate and/or support validation training, change control, and periodic review of validated systems, equipment, and processes
- Interface with management personnel to represent QA/Validation in project teams with the objective to assure that project quality objectives are met
- Provide technical decision-making regarding cGMP compliance, regulatory issues, validation strategy, and quality systems and/or strategic activities
Interim Validation Manager
Trilink
06.2021 - 05.2022
- Developed and implemented Computer Software Validation Program, including guidelines for the Master Validation Plan, procedures, policies and validation templates
- SME for system qualification and software validation under FDA regulations
- Reviewed and/or maintained change control activities in support of policies and procedures per regulatory requirements
- Provide leadership and technical decisions making for Management and high-level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems
- Develop and execute validation packages for the QC Laboratory including Sterilizers, HPLC, Incubators, Gas Chromatographers, Laminar Flow Hoods, Spectamax, Endotoxin, Endoscan, Freestyle, Excalibur, KF Comm, Spectrometer, Centrifuges, Balances, Moisture Analyzers, XRD, XRF, Temperature Mappings, Orbital Shakers, Biological Safety Cabinets
- Stability Chambers, pH Meters, FTIR, UV-VIS, Particle Analyzer, GC MS, Osmometer, Conductivity Meter, Assay Reader, Viscometer
- Approved system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is reported to support validation activities
- Write, revise, and review Assessments related to the Qualification and Validation of all critical components and systems
- Facilitate and/or support validation training, change control, and periodic review of validated systems, equipment, and processes
- Interface with management personnel to represent QA/Validation in project teams with the objective to assure that project quality objectives are met
- Provide technical decision-making regarding cGMP compliance, regulatory issues, validation strategy, and quality systems and/or strategic activities
Sr. Computer System Validation Engineer
Orasure
11.2020 - 03.2021
- Review current Risk Assessment for Call Center Test Scripts for COVID-19
- Review the FDA approved IFU
- Create, Update and the Implementation of Rx and OTC COVID-19 Call Center Test Scripts
- Create Training deck for Call Center Representatives
- Work with the COVID team to support and monitor efforts
- Ensured documentation met quality standards, applicable regulatory compliance and company guidelines
- Provide regular reports to management
Sr. Lead Validation Engineer/Quality Oversight
Mylan Pharmaceutical
01.2018 - 04.2020
- Responsible for the remediation and re-qualification which includes the development and execution of 60 test protocols for Granulation, Compression, Encapsulation, Coating, Inspection, Packaging, Maintenance and Warehouse systems
- Responsible for developing the URS, DS, and IQ, OQ, PQ protocols
- Created and executed CSV/Automation IOQs for manufacturing vision inspection systems, filling machines, Delta-V and packaging systems
- Lead the enhancement of cleaning practices, “clean in place” equipment and introduction
- Create cleaning cycle development strategies for a variety of equipment including clean-in-place systems, packaging equipment, parts washers, and production facilities
- Performed risk assessment and gap analysis for site cleaning programs
- Performed gap assessments and validation for PLC Manufacturing equipment, Laboratory and ERP systems
- Manage the CSV Validation staff by training full-time employees (FTE) and consultants
- Develop and maintain CS validation lifecycle maintenance including validation documentation, hierarchy, management, etc
- Demonstrate a solid understanding of FDA validation guidelines and industry best practices
- Implement policies and procedures to validate/verify equipment, computer systems, and processes in accordance with regulatory requirements and company standards
- Coordinate, direct, and lead validation efforts; Including equipment, process, and computer system validation
- Effectively manage and assign resources to address priority projects, meet schedules, maximize productivity, reduce costs, and increase efficiencies
- Work with Site Quality, Global Quality, Site IT, Global IT, QC Laboratory and R&D Laboratory, Manufacturing/Operational, Regulatory, Engineering, and upper Management Subject Matter Experts (SME) for remediation projects, day-to-day business projects and to support and prepare FDA agency audits
- Provide validation training to engineers, manufacturing/operations, laboratory, or other staff on validation protocols and standard operating procedures
- Provide regular reports to management
- Coordinate and participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing and system level testing on new and legacy systems
- Development of CSV remediation documentation (VP, URS, FRS, CS/DS, IQ, OQ, PQ, TM, VR) for legacy and new laboratory equipment / systems, and manufacturing equipment
- Documentation and closure of deviations generated during qualification activities execution
- Performed and support 21 CFR Part 11/ GAMP 5 remediation validation exercise for legacy manufacturing equipment during remediation project
- Perform high-level business and technical analysis such as value-stream mapping, requirements definition, validation planning, and gap analyses from user requirements
- Design, develop, and execute test scripts from software requirements for computer system validation
- Generate, execute, review, and complete validation documentation required (Traceability Matrix, URS, IQ/OQ/PQ protocols, and summary reports)
- Approved system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is reported to support validation activities
- Compile and analyze validation data and maintain validation documentation
- Write, revise, and review Assessments related to the Data Integrity, Qualification and Validation of all critical components and systems
- Facilitate and/or support validation training, change control, periodic review of validated systems, equipment, and processes
- Interface with management personnel to represent QA/Validation in project teams with the objective to assure that project quality objectives are met
- Provide technical decision-making regarding cGMP compliance, regulatory issues, validation strategy, and quality systems and/or strategic activities
- Ensure Change Control Management was followed in accordance with company policy & procedures
Sr. Computer Software Validation Engineer, Lead
Zest Dental Solutions
03.2018 - 09.2018
- Implementation of LabVantage, Bartender, Excel Spreadsheets, and Trackwise
- Developed and implemented Computer System Validation Quality Project Plan
- Developed and implemented Computer Software Validation Program, including guidelines, procedures and templates
- SME for system qualification and software validation under FDA regulations
- Reviewed and/or maintained change control activities in support of policies and procedures per regulatory requirements
- Provide leadership and technical decisions making for Management and high-level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems
- Develop and execute validation packages
- Approved system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is reported to support validation activities
- Write, revise, and review Assessments related to Data Integrity, Qualification and Validation of all critical components and systems
- Performed System Development Life Cycle for computer systems
- Developed and / or executed Validation Plans, User Requirements, and System Specifications for Computer Systems (Made2Manage, Bartender Print Station, LIMS, Excel Spreadsheets, etc.)
- Create and Review Department SOPs for content and compliance with regulatory requirements
- Analyze data associated with validation protocols, CVS Validation
- Develop and review test plan, user requirements specifications, validation plan, GMP assessment, Data Integrity assessments, validation summary, traceability matrices, scenario maps to ensure requirements are met
- Develop validation protocols and associated summary reports
- Create, review and approve risks involved in application/software validation
- Perform technical reviews and interprets data for accuracy of systems for completed validations/re-validations
Sr. Computer Software Validation Engineer, Lead
Lonza Houston
08.2017 - 03.2018
- Developed and implemented Computer System Validation Master Project Plan, Freezers, validation of the control systems for an integrated Packaging Execution System (PES) used to process over the counter (OTC) pharmaceutical products subject to FDA regulatory oversight
- Technical lead for the validation of the control system used to automate the functions of a GxP Clean-In-Place (CIP) system supporting the manufacturing of active ingredients
- Developed and implemented Computer Software Validation Program, including guidelines, procedures and templates
- SME for system qualification and software validation under FDA regulations
- Provide leadership and technical decisions making for Management and high-level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems
- Develop and execute validation packages
- Approved system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is reported to support validation activities
- Write, revise, and review Assessments related to the Qualification and Validation of all critical components and systems
- Performed System Development Life Cycle for computer systems
- Developed and / or executed Validation Plans, User Requirements, and System Specifications for Computer System and Equipment/Instruments
- Write and Review Department SOPs for content and compliance with regulatory requirements
- Analyze data associated with validation protocols, CVS Validation
- Develop and review test plan, user requirements specifications, validation plan, GMP assessment, Data Integrity assessments, validation summary, traceability matrices, scenario maps to ensure requirements are met
- Develop validation protocols and associated summary reports
- Create, review and approve risks involved in application/software validation
- Perform technical reviews and interprets data for accuracy of equipment for completed validations/re-validations
Sr. Computer Software Validation Engineer (Laboratory)
Nanotherapeutics
05.2017 - 08.2017
- Team Leader responsible for the decommissioning, relocation and requalification of QA In-Process and Finished Product Laboratory and computer systems
- Equipment included: Sterilizers, HPLC, Incubators, Gas Chromatographers, Laminar Flow Hoods, Spectamax, Endotoxin, Endoscan, Freestyle, XCalibur, KF Comm, Spectrometer, Centrifuges, Balances, Moisture Analyzers, XRD, XRF, Temperature Mappings, Orbital Shakers, Biological Safety Cabinets
- Stability Chambers, pH Meters, FTIR, UV-VIS, Particle Analyzer, GC MS, Osmometer, Conductivity Meter, Assay Reader, Viscometer
- SME for system qualification and software validation under FDA regulations
- Strong analysis, verification, validation
- Support clients by analyzing product results; developing product enhancements
- Develop and execute IQ/OQ/PQ in for analytical equipment in the QC Lab and LIMS to ensure complete validation in adherence to cGMP and 21 CFR 11 requirements
- Develop final report packages by analyzing results and preparing summaries of the data to support test and protocol requirements
- Developed testable system requirements
- Analyzed requirements for testing purposes
- Performed System Development Life Cycle for computer systems
- Developed and executed Validation Plans, User Requirements, System Configuration Specifications, Design Specification and Trace Matrix for Computer System and Equipment/Instruments in accordance with company SOP governed by ISO 13485; Quality System Regulation 21, C.F.R
- Part 820; IEC 62304 for Laboratory Instrumentation/Equipment
- Assessed risks involved in processing steps
- Strong analysis, verification, planning, and project management
- Scheduled and maintained SQL backups, reviewed and verified security access to SQL databases, and validated data points
Software Engineer SME, Lead
Sigma-Aldrich
08.2016 - 05.2017
- Developed and implemented Computer Software Validation Program, including guidelines, procedures and templates
- SME for system qualification and software validation under FDA regulations
- Reviewed and/or maintained change control activities in support of policies and procedures per regulatory requirements
- Provide leadership and technical decisions making for Management and high-level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems
- Develop and execute validation packages
- Approved system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is reported to support validation activities
- Write, revise, and review Assessments related to the Qualification and Validation of all critical components and systems
- Performed System Development Life Cycle for computer systems
- Developed and / or executed Validation Plans, User Requirements, and System Specifications for Computer System (ERP) and Laboratory Instruments/Equipment, LIMS (Labware), Blue Mountain RAM, Elpro
- Write and Review Department SOPs for content and compliance with regulatory requirements
- Analyze data associated with validation protocols, CVS Validation
- Develop and review test plan, user requirements specifications, validation plan, GMP assessment, Data Integrity assessment, validation summary, traceability matrices, scenario maps to ensure requirements are met
- Develop validation protocols and associated summary reports
- Create, review and approve risks involved in application/software validation
- Perform technical reviews and interprets data for accuracy of equipment for completed validations/revalidations
Validation Engineer
Thermo Fisher Scientific
03.2016 - 09.2016
- Technical lead for the validation of the control system used to automate the functions of a GxP Clean-In-Place (CIP) system supporting the manufacturing of active ingredients
- Authored documentation for Delta-V process control systems
- Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources
- Created validation test scripts and procedures
- Strong analysis, verification, validation
- Support clients by analyzing product results; developing product enhancements
- Develop and execute IQ/OQ/PQ in Laboratory environment
- Develop written final report packages by analyzing results and preparing summaries of the data to support test and protocol requirements
- Develop written final report packages by analyzing results and preparing summaries of the data to support test and protocol requirements
- Develop and execute IQ/OQ/PQ Excel Spreadsheets and SoftMax templates
- Develop and execute IQ/OQ/PQ File Transfer Service
- Develop and execute IQ/OQ/PQ Jump software
- Conduct audits of validation or performance qualification processes to make sure compliance with internal or regulatory requirements
- Perform technical reviews and interprets data for accuracy of equipment for completed validations/revalidations
- Write, revise, and review SOPs related to validation/revalidation activities
- Write, revise, and review GAP Assessments related to the Qualification and Validation of all critical components and system level instruments
- Perform Periodic Review, Data Integrity assessment, identify and document GAP Assessments, for Computer Systems, Equipment and Instruments
- Performed System Development Life Cycle for computer systems
- Developed and / or executed Validation Plans, User Requirements, and System Specifications for Computer System and Equipment/Instruments
Equipment Validation Engineer
Allergan
12.2015 - 03.2016
- Developed and / or executed Validation Plans, User Requirements, and System Specifications for Computer System and automated Equipment/Instruments
- Created validation test scripts and procedures
- Strong analysis, verification, validation
- Strong Quality CAPA, Deviation Investigations, OOS Investigations
- Support product by creating and testing functional and design documentation for automation line
- Support manufacturing by developing manufacturing test procedures
- Support clients by analyzing product results; developing product enhancements
- Develop and execute IQ/OQ/PQ in an aseptic environment
Education
Bachelor of Engineering - Chemical Engineering
Purdue University
Lafayette, IN05.2010
Bachelor of Science - Chemistry
University of Cincinnati
Cincinnati, OH05.2007
Bachelor of Science - Chemistry
Ivy Tech State College
Terre Haute, IN05.2005
Skills
- Hands-on experience in team leadership
- Contributor to industry, excellent communicator, and strong technical writer
- Data Integrity
- Validation of laboratory instruments
- Quality assurance oversight
- Manufacturing Validation, Laboratory Validation, Line Process experience
- Decommissioning
- Proficient in statistical analysis tools
- Process Characterization and Validation Methodology
- Design of Experiments (DOE)
- Line Process Documentation Technical skills in Process Control
- Excellent team player and interpersonal skills
- Excel Spreadsheet Validation
- Software Validation (CSV), Equipment Validation, Process Validation, Quality Oversight, Test Method Development, Test Equipment Automation, Test Method Validation
- Remediation
- Internal Audit/Assessment
- Periodic Review
- Regulatory Compliance Issues, Quality Assurance Standards
- Investigations; OOS, Deviations, Complaints, CAPA
Validation Expertise Overview
Bioreactors, Mixers, Dryers, Packaging Equipment, Filling machines, Capping Machines, Sterilizers/Autoclaves, Granulators, Fluid Beds, Tablet Press Systems, Clean in Place (CIP), Temperature Control Units, Roller Compactors, Encapsulate Tablet Testers, Washer Tunnel, Allen Bradley Process Control Systems, Emerson DeltaV, SCADA, FactoryTalk, Process Control Networks, OPC Servers, Manufacturing Execution Systems, Sterilizers, HPLC, Incubators, Gas Chromatographers, Laminar Flow Hoods, Spectamax, Endotoxin, Endoscan, Freestyle, XCalibur, KF Comm, Spectrometer, Centrifuges, Balances, Moisture Analyzers, XRD, XRF, Temperature Mappings, Orbital Shakers, Biological Safety Cabinets, Stability Chambers, pH Meters, FTIR, UV-VIS, Particle Analyzer, GC MS, Osmometer, Conductivity Meter, Assay Reader, Viscometer
Timeline
Sr. Validation Engineer, CSV SME/Quality Oversight
Cooper Surgical
01.2023 - 01.2025
Sr. Validation Engineer, Quality Oversight (CSV)
Seres Therapeutics
04.2022 - 05.2023
Interim Validation Manager
Trilink
06.2021 - 05.2022
Sr. Computer System Validation Engineer
Orasure
11.2020 - 03.2021
Sr. Computer System Validation Engineer
Organogenesis, Inc.
04.2020 - 01.2025
Sr. Computer Software Validation Engineer, Lead
Zest Dental Solutions
03.2018 - 09.2018
Sr. Lead Validation Engineer/Quality Oversight
Mylan Pharmaceutical
01.2018 - 04.2020
Sr. Computer Software Validation Engineer, Lead
Lonza Houston
08.2017 - 03.2018
Sr. Computer Software Validation Engineer (Laboratory)
Nanotherapeutics
05.2017 - 08.2017
Software Engineer SME, Lead
Sigma-Aldrich
08.2016 - 05.2017
Validation Engineer
Thermo Fisher Scientific
03.2016 - 09.2016
Equipment Validation Engineer
Allergan
12.2015 - 03.2016
Bachelor of Science - Chemistry
University of Cincinnati
Bachelor of Science - Chemistry
Ivy Tech State College
Bachelor of Engineering - Chemical Engineering
Purdue University
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