Pratiksha Kharate
Troy
Summary
Ms. Kharate has (6+) years of commissioning qualification validation (CQV) experience in the biopharmaceutical/biotech industry specializing in equipment, utilities, computerized automated systems (CSV), and aseptic fill/finish systems in compliance with global regulatory requirements including FDA 21 CFR Part 210, 211, 810, EU Annex 11, EU Annex 15, ICH Q7, GxP and cGMP guidelines. She is experienced in implementing data integrity principles in accordance with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) and GDPs (Good Documentation Practices). She is proficient in development, execution, and review of validation strategies, protocols (IQ, OQ, PQ), validation summary reports, conducting risk assessments, troubleshooting issues, and implementing corrective and preventive actions to optimize manufacturing processes. Led and supervised multidisciplinary teams of validation engineers, technicians, and specialists in the pharmaceutical industry, ensuring alignment with project objectives, regulatory standards, and company policies. Adept at collaborating with cross-functional teams to deliver compliant, audit-ready systems in highly regulated environments.
Overview
6
6
years of professional experience
Work History
Validation Engineer
Regeneron
Rensselaer, NY
09.2024 - Current
- Supported commissioning and Installation/Operation Qualification (IQ/OQ) protocol of an automatic nested syringe and vial inspection line, including development of Validation Master Plan (VMP), User Requirement Specification (URS), Design Qualification (DQ) assessment, 21 CFR Part 11 compliance evaluation, data integrity assessment, alarm criticality assessment to ensure cGMP compliance.
- Developed and executed Performance Qualification (PQ) protocol for an automatic nested syringe and vial inspection line to evaluate defect detection for flange, product, plunger, glass, soft needle shield, rigid needle shield, particulate foreign matter. Verified that Automatic Reject Zone Efficiency (AREZ %) met or exceeded Manual Reject Zone Efficiency (MRZE %) across all camera groupings.
- Led deviations, investigations, and root cause analyses using 5-Why, Fishbone, Failure Mode and Effects Analysis (FMEA) methodologies, and implemented Corrective Actions and Preventive Actions (CAPA) to prevent recurrence and improve robustness of the systems.
- Collaborated cross-functionally with Manufacturing, Engineering, and QA to align processes, close gaps, and standardize SOPs enhancing operational efficiency.
- Authored an addendum to the IQ/OQ protocol for the automatic nested syringe and vial inspection line to address additional modifications, including the integration of a new camera, SVObserver upgrade, relay upgrade, date format adjustment on the HMI, and updates to the data collector.
- Responsible for reviewing, compiling, and routing the Engineering Turnover Package (ETOP) documentation for the commissioned equipment.
- Reviewed site acceptance tests (SAT) and commissioning protocols as a QA Validation expert in order to leverage these tests in validation IQ/OQ protocols for automated visual inspection machine.
- Drafted, executed, and summarized an airflow visualization study (smoke study) for a syringe filling line isolator under both at-rest and operational conditions to demonstrate compliance with Grade A and C environmental standards, ensuring no contamination risk, in alignment with EU GMP Annex 1 and FDA Guidance for Sterile Drug Products Produced by Aseptic Processing.
- Developed and executed the Environmental Monitoring Performance Qualification (EMPQ) protocol for the filling line isolator, encompassing non-viable particulate, viable particulate, and viable settle plate sampling under static conditions. Reviewed and analyzed the collected data to confirm compliance with established acceptance criteria.
- Maintained complete and compliant documentation in ValGenesis/Veeva/TrackWise/LIMS.
- Utilized industry best practices including ISPE Baseline Guide Vol. 5 (Commissioning & Qualification), ISPE GAMP 5 risk-based approach for GMP computerized systems, and ASTM E2500 standards for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment.
- Led validation protocols for biopharmaceutical processes, ensuring compliance with regulatory standards.
- Developed and executed comprehensive test plans, enhancing product reliability and performance.
- Managed multiple validation projects simultaneously while adhering to strict deadlines and budget constraints.
- Utilized statistical tools such as Six Sigma methodologies contributing to data-driven decision making during validation processes.
Validation Engineer
Pfizer Inc
Rocky Mount, NC
08.2020 - 08.2024
- Authored and executed IQ/OQ protocol for Small Volume Parenteral (SVP) fully integrated Bosch Syringe Filling Line to qualify newly upgraded washer safety circuit and diverter system with installation of a new Human Machine Interface (HMI) to improve alarm handling capabilities. Tested newly upgraded Syringe Line Washer Door Safety Switches and E-STOP buttons.
- Drafted and executed IQ/OQ protocol for a new Servomotor Diverter for the Optima washer to adequately process syringe barrels without inflicting unacceptable damaged units.
- Drafted Traceability Matrix for SVP filling lines and associated equipment.
- Qualified piping modifications to the Vial Isolator Filling Line to improve the filling process and prevent potential exposure to the sterile pathway to leak contamination.
- Performed Installation and Operational Qualification on newly installed Piercan USA gloves for the Vial Filling Line isolator with higher thickness to reduce the number of holes in gloves reported across the filling lines onsite.
- Performed Operational Qualification for sterilization temperature range changes for ATEC Processor Filter stations Steam-in-Place (SIP) cycle. Verified the specifications, alarm assessment, and critical and non-critical Good Manufacturing Practice (GMP) instrumentation calibration status impacted by the temperature ranges modification.
- Validated newly installed Oil Free Compressed Air (OFCA) at Equipment Cleaning Area (ECA) Filter Drying Station.
- Tested communication faults between the Syringe filler PLC and Formulation PLCs. Validated newly added additional statuses within the Filler HMI that are applicable to production run.
- Performed Installation and Operational Qualification of fully aseptic new diaphragm valves of the Solution Tank to provide design improvements over the semi-aseptic valves, based on holding temperature/pressure and flowrate technical specifications.
- Performed and reviewed P&ID Walk down of all systems of the facility to verify if all the predetermined acceptance criteria are in accordance with the specifications of the User Requirement Specification, Functional Requirement Specification and Facility Design Specification.
- Drafted and executed IQ/OQ protocol for Vial Filling Line with physical and automated improvements to ensure proper controls are in place to maintain the sterility of the Vial Filling Line’s Clean in Place (CIP) and Sterilization in Place (SIP) system:
- System and User protection against valve failure modes and related alarm response controls.
- The Filler system detects whether the Clean in Place (CIP) and Sterilization in Place (SIP) system is in Solution Delivery and in sterile state prior to filling units.
- The CIP/SIP system requires users to be logged into the CIP/SIP HMI system to acknowledge alarms and prior to starting a cycle.
- Accountable for review, approval and release of Manufacturing and Packaging Batch Records.
- Vial Line requires supervisor acknowledgement only for critical alarms.
- Generated Computer Classification Assessment (CCA), Electronic Record and Electronic Signature (ERES) Data Integrity assessments to identify the Good Automated Manufacturing Practice (GAMP) category GAMP 5 and GAMP 4 to ensure GxP compliance to 21 CFR part 210, 211 and 820.
- Drafted Administration Standard Operating Procedures (SOP) to describe the roles and responsibilities and instructions for maintaining/updating newly installed Syringe Line Washer System for any type of alterations made to the system, including but not limited to, password changes, calibration, and process parameter changes.
- Drafted and executed Automated Process Controls (APC) IQ/OQ protocol for Hardware and Software verification, Communication Verification, HMI Access Security Matrix Verification, Software Backup Verification, Source Code Reviews, Maintenance Logbook Entries, and Electronic Adjudication Management System (EAMS) Workorders.
- Implemented and managed change control processes using Global Quality Tracking System (Trackwise) in accordance with FDA regulations and GMP guidelines.
- Assisted in the investigation of deviations and non-conformances to identify root causes and implement corrective actions to prevent recurrence.
- Conducted risk assessments to evaluate potential impacts on product quality during the validation phase.
- Established strong working relationships with vendors ensuring smooth communication during project deployment.
- Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
- Met tight deadlines to satisfy client demands and project timelines.
- Developed and executed validation protocols, enhancing overall efficiency of production workflows.
Validation Specialist
AMRI Global
Albuquerque, NM
12.2019 - 07.2020
- Conducted utility system qualification for clean steam, water for injection (WFI), compressed air systems, Oxygen, and Nitrogen supporting aseptic manufacturing.
- Reviewed and assessed change requests for completeness, accuracy, and potential impact on product quality and regulatory compliance.
- Updated Alarm Assessment, Site Drawings, User Requirement Specifications (URS), Software Design Specifications (SDS), Hardware Design Specifications (HDS).
- Authored, executed and summarized decommissioning protocol for Kay Validator.
- Performed IQ/OQ/PQ validation for Autoclave, Isolators/RABS, Depyrogenation Tunnel, CIP/SIP system, Lyophilizers, Bioreactors.
- Validated SCADA, PLC-based automation systems, and environmental monitoring software.
- Validated automated packaging lines including labeling, serialization, and vision inspection systems.
- Performed Computer System Validation following GAMP 5 methodology for automated manufacturing and monitoring systems.
- Performed data integrity assessments in alignment with ALCOA+ principles.
- Supported aseptic processing validation including media fills, equipment qualification, and cleanroom environmental monitoring compliance.
- Coordinated commissioning and qualification activities for new manufacturing equipment and utilities.
- Ensured validation documentation complied with FDA, cGMP, EU Annex 11/15, and 21 CFR Part 11 requirements.
- Supported deviation investigations, change controls, and CAPA implementation related to validation activities.
- Authored and reviewed validation protocols, traceability matrices, and summary reports.
- Produced and maintained technical documentation for project reference.
Education
Master of Science - Health Informatics
University of Findlay
Ohio, USA05.
Bachelor’s - Pharmacy
University of Pune
India10.2016
Skills
- Validation: Computer System Validation (CSV), Equipment, Utility, Aseptic Fill/Finish Manufacturing, Validation Master Plan (VMP), Design Qualification (DQ), User Requirement Specification (URS), Functional Requirement Specification, Hardware and Software Specification (HDS and SDA), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Risk Assessment, Electronic Records and Electronic Signature (ERES) Assessment, Installation, Operational, Performance Qualification (IQ/OQ/PQ) Protocol Development & Execution, Deviations, Corrective Actions and Preventive Actions (CAPAs), Validation Summary Report (VSR), Commissioning and Qualification (CQV), Decomissioning
- Compliance & Quality: cGMP, GxP, GAMP 5 and 4, 21 CFR Part 210, 211, 810, EU Annex 11, EU Annex 15, ICH Q7, ALCOA Data Integrity, Quality Risk Management
- Systems & Equipment: Automated Visual Inspection Machine, HMI/PLC/SCADA, Aseptic Syringe/Vial/Ampoule Filling Lines, Isolators/RABS, Autoclaves, Washer, Process Filter Stations, CIP/SIP, Bioreactors, Depyrogenation Tunnel, Lyophilizers, EMPQ, HVAC, Compressed Air, Utilities, Air Visualization/Smoke Study, Media Fills,
- Methodologies: Root Cause Analysis (5-Why, Fishbone), FMEA, CAPA, Change Control
- Software/Tools: ValGenesis, Veeva, TrackWise, LIMS, EAMS EDMS
Timeline
Validation Engineer
Regeneron
09.2024 - Current
Validation Engineer
Pfizer Inc
08.2020 - 08.2024
Validation Specialist
AMRI Global
12.2019 - 07.2020
Master of Science - Health Informatics
University of Findlay
Bachelor’s - Pharmacy
University of Pune