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Nithej Talluri
Senior Validation Engineer
Looking for roles like Senior Validation Engineer.
Highly skilled Senior Validation Engineer with 10+ years of hands-on experience in Equipment Validation and Computer System Validation (CSV) across pharmaceutical and biotechnology industries. Recognized for successfully leading validation projects that ensure operational excellence, compliance with FDA 21 CFR Part 11, GAMP 5, and ISO 13485/14971 standards, and readiness for regulatory inspections. Expert in validating a wide range of laboratory and manufacturing equipment, including autoclaves, HPLCs, GC systems, incubators, stability chambers, thermal cyclers, and environmental monitoring systems. Proficient in designing, executing, and managing IQ, OQ, PQ protocols, along with the creation of comprehensive validation plans, reports, and traceability matrices (RTM). Adept at ensuring data integrity compliance for systems like LIMS, SCADA, QMS, and ERP platforms, supporting seamless integration and functionality across operational workflows. Well-versed in conducting risk assessments, implementing CAPAs, and performing failure mode and effects analysis (FMEA) to enhance system reliability and mitigate risks. Proven ability to troubleshoot complex equipment and system challenges, optimize validation processes, and drive process improvements that streamline operations. Collaborated with cross-functional teams to manage large-scale projects involving laboratory automation, system upgrades, and equipment lifecycle management. Skilled in vendor qualification, equipment requalification, and calibration, ensuring sustained performance and compliance with regulatory guidelines. Committed to fostering compliance excellence and operational efficiency while mentoring junior engineers in validation methodologies and regulatory practices. Hands-on expertise in leveraging advanced tools and methodologies such as SQL, Visio, HP ALM, TrackWise, Documentum, and automated validation solutions to enhance project execution. Passionate about ensuring that critical pharmaceutical equipment and systems meet stringent safety, quality, and performance standards to advance patient health and safety. Ready to bring real-time expertise and innovative solutions to dynamic and fast-paced regulatory environments.
KL University, India | 2010 - 2014
Koneru Lakshmaiah Education Foundation (KL University), India | 2010 - 2014
Cloning & Gene Expression Analysis Using PCR and qPCR Techniques
Developed a PCR-based cloning protocol for gene expression in E. coli, performed qPCR analysis to validate gene expression, gaining valuable experience in PCR-based assays applicable to cell therapy product testing. Hands-on experience with NGS sample preparation and quality control, aligning with the sample analysis and stability monitoring of cell therapy products.
Project: RNA Extraction and Purification for Gene Expression Studies June 2017 – September 2017
Conducted RNA extraction and purification using column-based methods, followed by qPCR, ensuring quality results, which supports your proficiency in RNA-based assays such as those used in cell therapy QC testing. Documented protocols and results following SOP guidelines, reinforcing your ability to develop and review analytical study data summaries and reports.
CVS Health, Providence, RI | March 2023 - PRESENT
Led the validation of Quality Management Systems (QMS) and product lifecycle management (PLM) systems post-equipment relocation to ensure system integrity. Designed architectural diagrams, process map/workflow and entity relation maps of the documents or process using MS Visio. Written User Requirements specifications, Functional Requirements specifications document, Design Specification document in compliance with 21 CFR PART 11 Requirements.
Centene, St. Louis, MO | June 2021 - February 2023
Assessed 21 CFR Part 11 Electronic Records, Electronic Signatures, audit Trails and Security events , Part 820, ISO 13485, ISO 14971. Validating Plateau Learning management system, Kofax capture Scanning software system as a remediation activity. Developed IQ/OQ/PQ protocols related document management systems using EMC. Involved in configuring and validating Laboratory Information Management System LIMS for QC and Clinical Laboratories
CoverMyMeds, Columbus, OH, | August 2019 - May 2021
Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document. Worked on change control documentation such as Change Request Form CRF's , Change Control Implementation Plan, Change Control Summary Report.
Bayer healthcare pharmaceuticals Inc, Whippany, NJ | February 2017 - July 2019
Led validation activities for pharmaceutical manufacturing systems, including autoclaves, incubators, HPLCs, GCs, centrifuges, thermal cyclers, tablet presses, lyophilizers, mixing tanks and automated storage systems and ERP systems in compliance with ISO and FDA guidelines. Responsible for writing and executing Installation qualification IQ, Operational Qualification OQ and Performance Qualification PQ protocols to check installation and successful operation of the application. Performed GAP Analysis and prepared Remediation Plans. Monitored and ensured data integrity compliance across systems during audits and routine operations.
Fortis Heath Care, India | September 2014 - November 2016
Maintained compliance with regulations GxP/Part11, SOPs and Quality Management Systems. Conducted manual testing for Rockwell automated products. Assisted in developing and reviewing Test Plans. Facilitated system and user acceptance testing. Reviewed IQ/OQ/PQ, test plans and test scripts. Validated systems by implementing Good Automated Manufacturing Practices GAMP-5 Developed Traceability Matrix to track the requirements during the QA Testing Phase. Approved traceability matrices, deviation forms and validation summary reports (VSR).
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