Aaron Gerry
Foristell,MT
Summary
Dynamic Project Manager with over 10 years of experience in computer systems, software, and equipment validation within GMP-regulated environments, including pharmaceuticals, biologics, and diagnostics. Expertise in CQV (IQ/OQ/PQ) and CSV (SDLC) computerized system validation ensures adherence to stringent quality systems. Proven success in authoring comprehensive site-wide validation strategies, detailed project plans, protocols, and reports to enhance FDA/cGMP compliance, streamline documentation processes, and improve audit readiness. Data-driven problem solver with a background in business analysis and certification in Software Project Management, complemented by bilingual proficiency in English and Korean.
Overview
1
1
Certification
10
10
years of professional experience
Work History
IT Project Manager
Mead Johnson Nutrition (Contract)
04.2026 - Current
- Led cross-functional teams to deliver complex projects on time and within budget.
- Created and managed CSV Testing plans and Validation Strategy.
- Developed project plans to align with organizational goals and resource availability.
- Implemented process improvements, enhancing operational efficiency across multiple projects.
- Managed stakeholder communications, ensuring alignment and transparency throughout theproject lifecycle.
- Streamlined project documentation processes, improving accessibility and compliance with standards.
- Oversaw quality assurance testing processes, ensuring that all software met organizational standards before deployment.
- Led and managed a staff of 15 team members engaged in administering complex IT infrastructure.
Validation Engineer
Kindeva Drug Delivery
04.2024 - 12.2025
- Collaborate with cross-functional engineering and regulatory teams to advance CDMO validation practices for next-generation drug delivery systems. Author and execute IQ/OQ/PQ protocols, perform risk assessments and supplier qualifications, and maintain documentation to ensure cGMP compliance and audit readiness.
- Analyzed validation data to support decision-making and optimize operational efficiency.
- Conducted training sessions on validation tools and techniques for engineering staff, fostering knowledge sharing.
- Mentored junior engineers in best practices for validation engineering methodologies improving team skillsets.
- Reviewed and approved validation documentation, ensuring accuracy and adherence to industry guidelines.
Quality Oversight
Abbott (Contract)
02.2024 - 09.2024
- Performed qualification and verification activities for diagnostic equipment, ensuring accuracy and reliability of test systems. Led root cause analyses, coordinated corrective actions with engineering and manufacturing, and improved the effectiveness of qualification activities through process standardization and documentation control.
- Collaborated with cross-functional teams to refine testing processes and improve product reliability.
- Led team in implementing automated testing frameworks to enhance efficiency of regression testing.
- Analyzed test results and presented findings to stakeholders, driving informed decision-making for product improvements.
Validation Engineer
CAI
01.2022 - 11.2023
- Developed and implemented site-specific validation programs to align customer facilities with regulatory and cGMP expectations. Authored validation strategies, protocols, and final reports; performed equipment and process qualifications (IQ/OQ/PQ) and acceptance testing. Trained client personnel on validation procedures and documentation best practices to ensure sustainable compliance. Coordinated with stakeholders to close findings and support inspection readiness.
- Led validation processes for software applications, ensuring compliance with industry standards and regulations.
- Developed and executed test plans, enhancing software reliability and user experience.
- Analyzed validation results to provide actionable insights for continuous improvement initiatives.
- Developed and executed validation protocols, enhancing product reliability and performance.
- Conducted root cause analysis on deviations during validation activities, enabling timely resolution of technical issues.
Validation Consultant
Quotient BioServices
10.2021 - 01.2022
- Developed and executed site qualification testing and methods; collected and analyzed acceptance data to support equipment commissioning and regulatory documentation. Collaborated with operations to translate test outcomes into corrective actions and validated remediation activities.
- Developed and executed validation protocols for manufacturing processes, enhancing operational efficiency.
- Led validation projects for biologics and pharmaceuticals, ensuring compliance with regulatory standards.
- Streamlined validation processes, reducing turnaround times while maintaining accuracy and quality standards.
- Mentored junior consultants on best practices in validation documentation and compliance requirements.
- Established strong relationships with vendors, securing high-quality equipment at competitive prices for critical validation projects.
- Ensured compliance with industry regulations by conducting thorough risk assessments and audits.
Validation Engineer II
Thermo Fisher Scientific
07.2020 - 10.2021
- Work with coordinating departments to ensure quality in our processes and products. Maintain qualification standards for equipment and procedures. Write, review, and edit protocols. Collect data and documentation for equipment test status. Perform Equipment and Process qualifications for Commissioning/IQ/OQ/ & PQ.
- Collaborated with cross-functional teams to ensure compliance with regulatory standards.
- Conducted risk assessments and identified areas for process improvement.
- Streamlined validation processes, reducing time-to-completion while maintaining accuracy.
- Analyzed data trends to drive continuous improvement in equipment performance and reliability.
- Utilized statistical tools such as Six Sigma methodologies contributing to data-driven decision making during validation processes.
- Developed comprehensive validation master plans to ensure alignment across all projects and stakeholders.
Validation Specialist
Thermo Fisher Scientific (Contract)
04.2020 - 07.2020
- Performed equipment and process qualifications, maintained qualification standards, and authored and revised validation protocols. Collected test data to support commissioning and ensured documentation met cGMP and internal quality requirements.
- Developed and executed test plans to assess reliability and performance of analytical instruments.
- Reviewed and approved validation documentation, ensuring accuracy and adherence to regulatory requirements.
- Mentored junior staff on best practices in validation processes, fostering a culture of continuous improvement.
- Led initiatives to streamline validation workflows, resulting in increased efficiency and reduced turnaround times.
Business Analyst
Viracor Eurofins Clinical Diagnostics (Contract)
07.2019 - 02.2020
- Captured and documented business requirements, assessed change impacts, and translated needs into clear specifications for developers. Authored and executed test plans, validated and delivered functionality, and supported implementation to ensure solutions met business objectives and quality expectations.
- Analyzed business requirements to identify process improvements and operational efficiencies.
- Developed data-driven reports to support decision-making and strategic planning initiatives.
- Collaborated with cross-functional teams to streamline workflows and enhance project deliverables.
- Actively participated in team meetings to share knowledge, exchange ideas, address challenges, and collaborate on potential solutions.
- Interacted with internal customers to understand business needs and translate into requirements and project scope.
- Supported software development projects by defining clear requirements and effectively communicating them to technical teams.
Systems Validation Specialist
PRA Health Sciences (ICON)
01.2018 - 07.2019
- Prepared, wrote, and finalized validation documentation; executed periodic equipment reviews and validation test cases. Supported CAPA and continuous improvement initiatives to enhance process reliability and regulatory compliance.
- Validated software and systems for compliance with regulatory standards.
- Collaborated with cross-functional teams to address validation issues effectively.
- Developed and executed validation protocols to ensure data integrity.
- Streamlined documentation processes to enhance efficiency and accuracy of validations.
- Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
Validation Technician
CEVA SANTE ANIMALE
03.2016 - 01.2018
- Qualified instruments, units, and processes used in vaccine and biologics production to support manufacturing and release.
- Compiled and formatted test data into professional reports used for regulatory licensing and approvals.
- Improved data collection and reporting accuracy to support regulatory submissions and product release timelines.
- Conducted validation tests to ensure compliance with regulatory standards and quality requirements.
- Developed and maintained validation protocols and documentation for product testing procedures.
Education
General Education - General Studies
Johnson County Community College
Overland Park, KS01-2015
Skills
- Project Management
- Power BI
- Visio
- Microsoft Office Suite
- Google Workcenter
- Architectural, P&ID and Schematic Drawing Review
- Quality Auditing
- Smartsheet
- Equipment Commissioning and Testing
- Clinical Research
- ISO, FDA, GxP Regulations
- Risk Management
- Operations
- IT infrastructure management
- Business analysis
- Test script development
- Computer system validation
- Software validation
- Qualification and Commissioning: Autoclave, Parts Washer, Depyrogenation Tunnel, Depyrogenation Oven, UV-VIS, Isolator, Filling Machine, Capping / Closing Machine, Label Machine, Finish Wrapping, Water for Injection (WFI) System, Reverse Osmosis (RO) System, De-Ionized Water (DI) System, Clean Compressed Air System, Clean Steam System, Oxygen Generation System, Nitrogen Generation System (N2), Carbon Di-Oxide System (CO2), Bioreactor, Fermentor, Mixer, Cleanroom, Lyophilizer , Patient Monitoring System, Refridgerators, Incubators, Freezers, Warehouse, Vacuum Chamber
- Testing and Verification: EN285 Steam Testing, Electrical Testing, Gram Staining, Air Quality, User Access, 21 CFR & Annex 11, Software Development Lifecycle (SDLC), Clean-In-Place (CIP), Steam-In-Place (SIP), Cleaning Validation, Sterility Hold, Cleaning Hold, Diagnostic, I/O Testing, User Acceptance Testing, Factory Acceptance Testing, Site Acceptance Testing, HEPA, Serial Inspection, Code Verification, SQL Testing, UX/UI Testing, Barcode Verification, Weld and Borescope Verification, Container Closure Integrity Testing (CCIT), Failure Mode and Effect Analysis (FMEA), Risk Analysis
- Documentation: Standard Operating Procedure (SOP), User Requirements (URS), Traceability Matrix (TRM), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification, Process Qualification, Validation Master Plan, Test Method Validation (TMV)
Certification
- Software Project Management, LinkedIn - Jan 2026
- Project Manager Foundations, LinkedIn, Jan 2022
Languages
Korean
Professional Working
Timeline
IT Project Manager
Mead Johnson Nutrition (Contract)
04.2026 - Current
Validation Engineer
Kindeva Drug Delivery
04.2024 - 12.2025
Quality Oversight
Abbott (Contract)
02.2024 - 09.2024
Validation Engineer
CAI
01.2022 - 11.2023
Validation Consultant
Quotient BioServices
10.2021 - 01.2022
Validation Engineer II
Thermo Fisher Scientific
07.2020 - 10.2021
Validation Specialist
Thermo Fisher Scientific (Contract)
04.2020 - 07.2020
Business Analyst
Viracor Eurofins Clinical Diagnostics (Contract)
07.2019 - 02.2020
Systems Validation Specialist
PRA Health Sciences (ICON)
01.2018 - 07.2019
Validation Technician
CEVA SANTE ANIMALE
03.2016 - 01.2018
General Education - General Studies
Johnson County Community College