Senior Validation Engineer
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Results-driven Senior Validation Engineer with extensive expertise in leading Commissioning, Qualification, and Validation (CQV) activities in FDA-regulated pharmaceutical and biotechnology environments. Proven expertise in lifecycle validation of GMP manufacturing equipment, sterility suite isolators, cleanroom systems, process utilities, laboratory instruments, temperature-controlled storage systems, and computerized systems. Experienced in managing validation projects from initiation through completion, including project planning, scheduling, risk management, milestone tracking, and cross-functional collaboration to ensure successful execution of CQV deliverables.
Demonstrated ability to lead multiple validation workstreams while maintaining compliance with cGMP requirements, project timelines, and business objectives. Strong technical background in aseptic processing, fill-finish manufacturing, VHP decontamination, environmental monitoring, cleanroom qualification, temperature mapping, and digital validation platforms such as Kneat. Skilled in authoring and executing validation lifecycle documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, traceability matrices, deviations, and final reports.
Recognized for driving complex qualification projects, including end-to-end commissioning and qualification of sterility suite isolators, while partnering effectively with Engineering, Quality Assurance, Manufacturing, Facilities, Automation, and Project Management teams to deliver compliant, inspection-ready systems in accordance with FDA regulations, GAMP 5, and industry best practices.
Senior Validation Engineer at Takeda Pharmaceuticals (2024-04 – Present) Led Commissioning, Qualification, and Validation (CQV) activities for GMP manufacturing equipment, cleanroom systems, process utilities, and facility infrastructure supporting pharmaceutical manufacturing operations.
• Managed validation project deliverables by supporting project planning, scheduling, milestone tracking, resource coordination, and execution of validation activities within established timelines.
• Collaborated cross-functionally with Engineering, Quality Assurance, Manufacturing, Facilities, Automation, and Project Management teams to ensure successful project execution and compliance with regulatory requirements.
• Authored, reviewed, and executed validation lifecycle documentation, including Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ Protocols, Requirements Traceability Matrices (RTM), Deviations, and Final Summary Reports.
• Coordinated multiple validation workstreams simultaneously, ensuring effective prioritization of activities, schedule adherence, and timely completion of project milestones.
• Applied risk-based validation methodologies and quality risk management principles in accordance with FDA cGMP regulations, GAMP 5, and industry best practices.
• Executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing for CIP Skid systems, verifying process controls, alarms, interlocks, automation functionality, and cleaning cycle performance.
• Conducted commissioning, loop checks, and qualification activities for Reverse Osmosis (RO) water systems, including flow verification, conductivity monitoring, sanitization verification, and system performance testing.
• Led end-to-end commissioning, qualification, and validation of Sterility Suite Isolators, including design review, turnover package assessment, risk assessments, protocol development, execution of IQ/OQ/PQ, VHP decontamination cycle qualification, Environmental Monitoring Performance Qualification (EMPQ), discrepancy resolution, and final validation reporting to support GMP manufacturing readiness.
• Developed and executed commissioning and qualification protocols for biosafety cabinets (BSCs), refrigerators, freezers, incubators, Cold Rooms and warehouse storage systems.
• Performed Environmental Monitoring Performance Qualification (EMPQ) activities for cleanrooms, isolators, and classified manufacturing environments to verify compliance with ISO and GMP requirements.
• Supported cleanroom qualification activities including airflow visualization, pressure differential verification, environmental monitoring coordination, and HVAC performance assessments.
• Reviewed turnover packages and engineering documentation including calibration records, weld logs, passivation reports, material certifications, and punch-list items prior to qualification execution.
• Executed temperature mapping and thermal validation studies utilizing Kaye AVS, Ellab, and calibrated data loggers, including loaded, unloaded, dynamic, door-open, and power-failure recovery testing.
• Developed and managed electronic validation documentation within Kneat, supporting digital validation lifecycle execution for direct and indirect impact systems.
• Performed field verification and walkdowns of process and utility systems to confirm installation compliance with P&IDs, engineering drawings, design specifications, and GMP requirements.
• Supported discrepancy investigations, risk assessments, corrective actions, and final turnover activities to ensure successful project completion and regulatory compliance.
• Contributed to continuous improvement initiatives by streamlining validation processes, enhancing documentation workflows, and improving efficiency within digital validation platforms.
Engineer at ThermoFisher Scientific (2024-02 – 2024-04) • Drafting and execution of IQ, OQ, PQ documents in Kneat for the GMP instrument • Validation support for the development and execution of protocols to support the qualification of equipment and equipment-related systems utilized in Quality Control in accordance with cGMP requirements.
• Execution of validation activities like performing Qualification and Re-qualification for CTUs with loaded chamber testing and generating the final report.
• Programming the Data loggers in Ellab for the qualification of CTUs.
• Qualifying the Building Management System (BMS) as per the client's requirements.
• Drafting the Analytical Balances protocols in Kneat and Execution.
• Developed the Commissioning Test Plan (CTP) protocol for High-Temperature, Short-time (HTST) Skids • Decommissioning of GMP & Non-GMP instruments.
Engineer at Pfizer (2022-01 – 2023-12) Led Commissioning, Qualification, and Validation (CQV) activities for GMP systems, including cold rooms, refrigerators, freezers, CO₂ incubators, liquid nitrogen (-156°C) storage systems, laboratory instruments, and manufacturing support equipment.
• Developed, reviewed, and executed validation lifecycle documentation, including URS, FRS, Risk Assessments, IQ/OQ/IOQ/PQ protocols, traceability matrices, deviations, and final reports in accordance with FDA cGMP, GAMP 5 and data integrity requirements.
• Performed temperature mapping and thermal qualification studies utilizing Kaye Validator systems and calibrated data loggers for controlled temperature units, storage environments, and laboratory equipment.
• Executed commissioning and qualification activities for CIP/SIP systems, verifying cleaning and sterilization cycle performance, automation controls, process parameters, alarms, interlocks, and system functionality.
• Executed autoclave qualification activities, including heat distribution studies, loaded and unloaded cycle qualification, temperature mapping, biological indicator verification, cycle development assessments, and Performance Qualification (PQ) testing to demonstrate sterilization effectiveness and compliance with GMP requirements.
• Authored and executed validation test scripts for analytical and automated laboratory systems, including HPLC, UPLC, plate readers, liquid handling platforms, and computerized systems.
• Led Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities with vendors and cross-functional stakeholders to verify equipment readiness, design compliance, and operational functionality.
• Managed calibration and maintenance activities for critical GMP instruments and equipment, including thermocouples and temperature monitoring devices, ensuring traceability and compliance throughout the validation lifecycle.
• Developed and maintained Data Integrity and Electronic Records/Electronic Signatures (DI-ERES) documentation to support compliance with FDA 21 CFR Part 11, ALCOA+, and computerized system validation requirements.
• Performed risk assessments, gap analyses, CAPA evaluations, deviation investigations, root cause analysis, and remediation activities to maintain validated system status and regulatory compliance. Coordinated validation execution across Quality Assurance, Quality Control, Manufacturing, Engineering, Facilities, and Maintenance teams to ensure successful project delivery and adherence to schedule. Managed change controls, periodic reviews, and lifecycle maintenance activities to ensure continued GMP compliance and validated state of equipment and computerized systems. Utilized LIMS, EAMS, and quality management systems to support sample management, equipment maintenance, calibration scheduling, documentation control, and validation record management.
· Authored and revised SOPs, work instructions, and lifecycle management procedures supporting operation, qualification, maintenance, and compliance of GMP systems.
· Supported regulatory inspections and audit readiness activities by ensuring validation documentation was complete, technically accurate, and inspection-ready.
Viatris – San Antonio, TX
· Developed and executed IQ/OQ/PQ protocols for analytical instruments, including HPLC, UPLC, UV-Vis spectrophotometers, and other laboratory equipment, ensuring compliance with cGMP and data integrity requirements.
· Performed temperature mapping and thermal qualification studies using Kaye Validator systems and calibrated data loggers for controlled temperature units, storage environments, and laboratory equipment.
· Authored and revised SOPs, work instructions, and lifecycle management documentation supporting equipment operation, qualification, maintenance, and GMP compliance requirements.
· Prepared commissioning, qualification, and validation documentation, including protocols, executed test records, and final summary reports to support regulatory compliance and system release.
Merck – West Point, PA
· Developed, reviewed, and executed validation lifecycle documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, deviations, traceability matrices, and final reports in accordance with FDA cGMP requirements and industry standards.
· Executed qualification testing for aseptic processing equipment, verifying installation, operational functionality, process controls, alarms, interlocks, recipe management, equipment sequencing, and system integration.
· Performed qualification of vial washers, depyrogenation tunnels, lyophilizers, and autoclaves, including temperature mapping, heat distribution studies, cycle development verification, critical process parameter assessments, and performance qualification testing.
· Supported startup, commissioning, and turnover activities by conducting equipment inspections, field verifications, P&ID walkdowns, punch-list resolution, and turnover package reviews.
· Performed cleanroom and facility qualification activities, including airflow visualization studies, pressure differential verification, environmental monitoring, and HVAC performance assessments.
· Qualified vial washer systems by performing commissioning support, IQ/OQ/PQ testing, cycle verification, critical process parameter assessment, alarm and interlock verification, and operational readiness evaluations to ensure compliance with validated cleaning requirements.
· Reviewed engineering documentation, including calibration records, material certifications, weld documentation, passivation records, and construction turnover packages to ensure qualification readiness.
· Supported regulatory inspection readiness by ensuring qualification documentation was complete, technically accurate, and compliant with GMP requirements.
· Contributed to successful project delivery through execution planning, discrepancy resolution, risk mitigation, and final turnover of validated systems for commercial manufacturing operations.
