Process Validation Continuous Improvement
Resume:
Sakshith Goud
**************@*****.***
Summary of Qualifications
Validation/CQV Engineer with experience in the pharmaceutical industry, specializing in aseptic and sterile manufacturing processes.
Ensured compliance with all applicable SOPs, safety regulations, and regulatory requirements for production of vaccines.
Proven track record in developing and executing validation protocols, ensuring compliance with cGMP, and FDA standards
Experienced in Fill Finish operations, including fillers, inspection machines, assembly machines, and packaging machines with sterilization experience, ensuring compliance with stringent pharmaceutical production standards.
Demonstrated experience in batch record audits, CAPA management, and cross-functional team collaboration to drive continuous improvement and maintain regulatory compliance. Proficient in executing qualification protocols for critical production equipment, utilities, and systems, with hands-on experience in environmental monitoring, aseptic process simulations, and media fill studies.
Experience in commissioning and qualification of equipment in Aseptic and clinical environments.
Experience in manufacturing Equipment Qualification, process validation and cleaning validation with strong knowledge of FDA 21 CFR part 11,21 CFR part 820 and other GxP Regulations
Professional Experience:
Pfizer, Rocky Mount, NC Dec 2024- Present
Process Validation Engineer
Reviewed and approved validation documentation, ensuring completeness, accuracy, and adherence to regulatory requirements.
Provided technical oversight for validation engineers during commissioning, qualification, and validation (CQV) projects.
Conducted sterility assurance validation, including media fill studies, aseptic process simulations (APS), and environmental monitoring to ensure product integrity.
Performed Failure Mode and Effects Analysis (FMEA) to identify potential risks in equipment qualification and process validation.
Assisted cross-functional teams in executing CQV activities, ensuring compliance with FDA, GMP, and regulatory guidelines.
Provided on-site technical support at CMOs, ensuring process consistency and adherence to GMP regulations.
Conducted Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for automation equipment used in fill/pack operations.
Worked on IQ/OQ/PQ/Calibrations of instruments used with refrigerators-freezers, equipment control functions (push buttons, switches, and indicators), autoclaves, incubators, refrigerators.
Developed and implemented risk-based validation approaches, reducing compliance risks while ensuring operational efficiency.
Conducted risk-based evaluations of equipment performance, identifying trends and recommending preventive maintenance strategies.
Supported development of best demonstrated CQV practices within the validation department, based on current industry practices and regulatory guidelines.
Sanofi Pasteur, Swiftwater, PA
Validation Engineer Apr 2023 – Dec 2024
Executed validation protocols for aseptic manufacturing processes, ensuring compliance with cGMP and regulatory standards, and successfully reducing contamination risks through rigorous process controls and environmental monitoring.
Developed detailed process validation reports and technical summaries using Microsoft Word and PowerPoint presentations for cross-functional teams.
Reviewed Risk Assessment Documentation, identified deficiencies, assessed CAPA and Change Control Requests (CCR), and developed Remediation Plans for project management approval following GAP Analysis.
Prepared study reports using the Kaye Validator for equipment physical tests, following established SOP guidelines. Worked closely with Manufacturing, Metrology, and CQV teams to resolve deviations and document equipment failures.
Assisted Engineering Change Control (ECC) processes to implement equipment and process modifications while maintaining compliance
Utilized Kneat for validation lifecycle management, ensuring efficient tracking and documentation of validation activities.
Reviewed and approved lyophilization protocols, deviation reports, and final validation reports to maintain validated state of equipment.
Worked with bioreactors, chromatography systems (HPLC, UPLC), and filtration systems for purification of biologics.
Ensured all validation activities complied with FDA 21 CFR Part 11 and EU Annex 11 requirements, maintaining high standards of data integrity and system security.
Drafted and reviewed validation documentation such as Plans, Protocols, Reports, SOPs, and Change Control Records, ensuring adherence to GDP guidelines with clarity, thoroughness, and precision.
Conducted physical testing on temperature-controlled equipment, including freezers, refrigerators, incubators, environmental chambers, ovens, cold rooms, and warm rooms.
Performed Requalification (RQ) activities on equipment to uphold validated status, adhering to IQ, OQ, and PQ protocols as necessary.
Executed temperature mapping and pressure hold testing on lyophilizers to validate uniform drying conditions and ensure compliance with FDA guidelines.
Created and executed policies and procedures ensuring compliance with regulatory standards for Commissioning, Qualification, and Validation (CQV) in manufacturing and support systems.
Collaborated and validated analytical instruments, including pH meters, Vi-Cells, Osmometers, HPLC, and UPLC.
Collaborated with cross-functional teams to complete FMEA analyses, and your proficiency in documenting findings and recommendations.
Performed temperature mapping of controlled temperature units using the Kaye Validator.
Executed validation protocols (IQ, OQ, PQ) for sterile fill/finish processes in compliance with FDA regulations, ensuring product quality and regulatory compliance throughout manufacturing
RK Pharma Solutions, Pear River, NJ
Validation/CQV Engineer Feb 2022 – Apr 2023
Prepared IQ, OQ, and PQ protocols for new or modified manufacturing equipment, processes, systems, facilities and Utilities.
Utilized Minitab to perform statistical analysis, including SPC and DOE, to monitor and improve process capability.
Maintained compliance with Good Manufacturing Practices (GMP) and other pertinent guidelines by ensuring that all CAPAs were in line with regulatory requirements.
Maintained accurate and detailed documentation throughout the CAPA process, including thorough investigation reports, action plans, and follow-up assessments.
Executed comprehensive performance tests on tablet presses, including uniformity of weight, hardness, thickness, and disintegration time to validate operational efficiency and product quality.
Developed and implemented validation strategies for aseptic fill/finish processes, including risk assessments, protocol generation, and execution, resulting in successful regulatory audits and product launches
Developed and executed FMEA for critical manufacturing equipment, identifying potential failure modes and implementing corrective actions to reduce downtime and enhance operational efficiency.
Utilized knowledge of laboratory instrumentation and equipment to troubleshoot and identify potential sources of deviations, ensuring accurate and reliable analytical results.
Implemented process improvement projects, integrating new procedures and optimizing equipment and tooling to enhance efficiency and quality. Supported the commercialization of new products through process characterization, validation, equipment procurement, and capacity planning activities.
Implemented Kneat to automate and streamline validation processes, improving the accuracy and traceability of validation documentation and accelerating project delivery.
Monitored CQV activities to ensure adherence to project timelines, providing regular updates during daily status meetings.
Assisted in executing environmental monitoring (static and dynamic testing) protocols using particle counters.
Developed and executed requalification protocols to challenge existing systems and to demonstrate they continued to remain in a validated state of control, including autoclave, retain/stability chambers, incubators, freezers, refrigerators, and cold rooms.
Developed Requirements Traceability Matrix (RTM) to map the user requirements to the functional requirements, design specification and the IQ/OQ/PQ test script references.
Ajanta Pharma USA Inc, Bridgewater, NJ Aug 2019 – Nov 2021
Validation/CQV Engineer
Executed installation, operational and performance qualification protocols for critical production equipment, utilities and processes which may include HVAC systems, clean compressed air systems, WFI systems, controlled storage units, autoclaves, SIP processes, and critical production equipment.
Performed change control assessments and write/review CQV plans, study/test protocols, and summary reports. Performed execution of study/test protocols and review test results.
Developed and maintained Validation Plans, Requirements Specifications, Risk Assessments, IQ/OQ, Traceability Matrices, and Validation Final Reports.
Drafted standard operating procedures (SOPs) and supported QA audits of existing operating procedures to ensure compliance with company current regulatory requirements.
Wrote, reviewed, and executed of validation documentation for manufacturing, packaging, facilities, and especially analytical equipment and cleaning.
Generated verification protocols for internal and external testing fixtures to verify the design met its requirements for intended use and to meet various regulatory standards for safety compliance. Generated documentation to report and discuss engineering design analysis and testing findings, technical memorandums, and follow up risk management report.
Documented end to end validation process for IRMS, TrackWise (CAPA, CCM) to ensure compliance with company policies and procedures.
Bhaskari Aqua Products Pvt. Ltd, Hyderabad, India Jan 2018 – Jan 2019
Associate Quality Engineer
Worked with the R&D team in the prototyping and testing team to explore all aspects of product development.
Worked with the Supplier Quality team to track and respond to specific NC (Non-Conformance) issues and managed the NC data logs; performed historical data searches, reviews, and reports.
Reviewed the product manuals, internal QA manuals, test procedures and reports, SOPs, and management reports.
Developed validation protocols to implement a paperless batch record system and trained the team of 3 members supporting further projects.
Reviewed batch documentation, conducting line inspections, line clearances, and in-process inspections during production, managing the controls and deviations, and documenting.
Reported Non-conformances, conduct the root cause analysis, and document any corrective and preventive actions (CAPA) taken.
Developed Kaizen boards, standard operating procedures, and personal protective equipment charts for various operations.
Conducted daily plant activities and kept track of incoming raw material and finished products at the end of each shift.
Education:
Masters in Industrial Engineering, State University of New York at Buffalo
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