Lokesh

CQV Engineer with 8+ years of GMP experience delivering commissioning, qualification, and validation (CQV) within GMP-regulated pharmaceutical and life sciences environments. Experienced in qualification of process equipment and utility systems including mixing vessels, solvent handling systems, process skids, heat exchangers, pumps, sterilization systems, HVAC, and controlled temperature Units (CTUs). Proven expertise across the full validation lifecycle including URS, FS, DS, DQ, RTM, IQ/OQ/PQ execution, deviation, deviation management, and risk-based validation activities.

Experienced in leading protocol development, design qualification (DQ) support, execution oversight, deviation investigations, and validation documentation review to ensure compliant, inspection-ready systems. Strong background in risk-based validation and cross-functional collaboration to support system design, utility planning, and quality-driven project execution. Demonstrated success across multi-site pharmaceutical projects, including large scale temperature and humidity mapping and 21 CFR Part 11-compliant electronic validation using ValGenesis, Kneat, and EDMS platforms.

CQV Engineer III - Millipore Sigma - Indianapolis, IN

(2024-11)

• Developing and executing Installation/Operational Qualification (IOQ) and Performance Qualification (PQ) protocols for Controlled Temperature Units (CTUs) such as Ultra-Low Temperature (ULT) Freezers, Laboratory Refrigerators, Incubators, Walk-In Freezers, and Walk-In Refrigerators.
• Executing and updating User Requirement Specifications (URS), Design Qualification (DQ), and System Risk Assessment (SRA) documents in compliance with site validation procedures and regulatory expectations.
• Executing qualification activities in ValGenesis, ensuring real-time documentation, traceability, and compliance with GMP and data integrity standards.
• Performing System Impact Assessments (SICA) and ensuring appropriate risk categorization, critical parameter identification, and mitigation through qualification testing.
• Collaborated with Project Leads, Client Engineers, and Quality Assurance to align on validation scope, acceptance criteria, and deviation resolution strategies.
• Supporting end-to-end validation lifecycle activities—including protocol authoring, field execution, discrepancy resolution, and report generation—for environmental chambers and laboratory systems.
• Acting as a technical SME for the validation team at site level, providing guidance on system functionality, test execution approach, and regulatory interpretation during protocol development.
• Participating in cross-functional meetings to review progress, discuss qualification challenges, and ensure on-time deliverable completion and audit readiness.
• Contributing to continuous improvement initiatives by standardizing IOQ templates, optimizing execution efficiency, and ensuring consistency across system qualification packages.

Validation Team Lead - American Regent - New Albany, OH

(2025-06 - 2025-12)

• Defined the scope and validation approach for Aseptic Rooms and CNC (Classified Non-Critical) Areas, ensuring alignment with project goals and regulatory expectations.
• Provided strategic input to utility system lead, including guidance on defining system boundaries to clarify scope and streamline validation planning in line with client expectations.
• Collaborated closely with client and internal stake holders to offer technical expertise and support throughout the validation lifecycle.
• Reviewed validation protocols and documentation to ensure technical accuracy, completeness, and readiness for client submission.
• Drafted IOQ protocols and documentation for CNC packaging and inspection Rooms.
• Coordinated with cross functional teams to track progress, resolve issues, and maintain high standards of quality and compliance.

CQV Engineer III - Millipore Sigma - Sheboygan, WI

(2024-05 - 2024-11)

• Executed commissioning and qualification activities for process equipment including solvent storage tanks, mixing vessels, and utility integrated manufacturing system within GMP pharmaceutical environments.
• Collaborated with cross-functional teams to troubleshoot and resolve commissioning and qualification issues, enhancing reliability and performance.
• Performed commissioning and qualification of centrifugal pump systems associated with solvent handling and mixing operations, ensuring with cGMP and requirements.
• Drafted and maintained detailed documentation, including validation summary reports and deviations, to ensure compliance with regulatory standards and internal quality guidelines.
• Executed IQ/OQ activities for solvent distribution systems including shell & tube heat exchangers, process piping interfaces, and associated utility connections.
• Supported qualification activities for skid-based systems supporting GMP manufacturing operations.
• Responsible for executing IQs with detailed inspections of equipment installations, verifying proper alignment, connections, and functionality of all components, including valves, pumps, and instrumentation.
• Conducted rigorous testing of operational parameters to confirm equipment met operational requirements.
• Collaborated with engineering, operations, and quality teams during commissioning and start up activities for process related manufacturing equipment.
• Execute cleaning validation activities for process tanks, mixing vessels, and manufacturing equipment within GMP pharmaceutical manufacturing environments, including swab sampling, rinse sample collection, equipment cleaning verification, and changeover support activities.

Validation Engineer II - CSL Plasma - FL

(2021-12 - 2024-03)

• Developing and executing the Installation Validation Project Plans, Validation Project Plan Reports, Validation Qualification Reports, Operational Qualification, Performance Qualification for the operation of the steam sterilization cycle of new Autoclaves of the generic medicine filling line processes.
• Authoring, executing, or reviewing Validation documents such as: Validation Qualification Protocols, Risk Management tools, Formulation Evaluations, and Deviation Handling for Autoclave and SIP sterilization studies using AVS Kaye Validators, Kaye Val-Probes and Data Tracers.
• Validating new designs of loading patterns for at least three different types of filling equipment for sterilization prior to installation onto the filling line processes and product fulfillment.
• Qualifying AVS Kaye validator thermocouples sensor systems for validation studies used for temperature mapping and profiling for all autoclaves.
• Executed IQ, OQ and PQ documentation in Kneat system.
• Supported qualification activities for SIP/sterilization related systems and thermal validation studies within GMP manufacturing operations.
• Knowledge of cGMP cleaning validation requirements and techniques, GMP process and product validation requirements and techniques.
• Working as a part of the Validation team addressing the Change Control Process and Corrective and Preventive Actions (CAPAs) to minimize the risks.

Validation Engineer - Dr. Reddys - Hyderabad, India

(2017-06 - 2021-07)

• Generated and executed Installation, Operational and Performance qualification (IQ, OQ, PQ) protocols, engineering studies and final reports that compiled with corporate and regulatory requirements.
• Performed a variety of validation activities, including IQ, OQ, PQ activities for Sterilization equipment and CTU (Controlled Temperature Units) such as autoclaves, VHP chambers, freezers, Refrigerators.
• Supporting cleaning validation activities for a variety of client projects such as a new product transfer into facility, facility capacity increase and process change support.
• Developed risk assessments, deviation responses and summary reports for qualification activities.
• Providing technical expertise to define approache