Abhay Sistla
Raleigh,NC
Summary
One year of experience in Validation Engineering within the biopharmaceutical and pharmaceutical industries. Comprehensive knowledge and experience in technical writing of Validation protocols, including IQ, OQ, PQ, Validation Summary Report, and Requirement Traceability Matrix in FDA-regulated environments, EU, and ICH GMP requirements. Expertise in Equipment Validation, Process Validation, risk assessment, FMEA, Change Control, CAPA, and Deviations. Skilled in performing periodic reviews and GAP analysis to identify compliance gaps, developing CAPA plans, and implementing them. Strong understanding and working experience in cGXP environments, FDA's 21 CFR Parts 11, 210, 211, and 820, ICH-GCP Guidelines, and ISO 13485. Proficiency in P&ID walk-downs and identifying red lines for complex process and manufacturing equipment. Conducted temperature mapping using Kaye Validator. Experienced in gowning/de-gowning procedures and certifications, working in ISO5 and ISO7 clean rooms. Excellent communication skills to effectively interact with Quality Control, Quality Assurance, Engineering, and Facilities groups.
Overview
2
2
years of professional experience
Work History
Principal Validation Engineer
ThermoFisher Scientific
01.2024 - 03.2024
- Compiled, prepared and reviewed validation deliverables such as Installation and Operational Qualification (IOQ), Performance Qualification (PQ), and Validation Summary reports for TCUs
- Coordinated and managed the validation and qualification strategy for the equipment
- Performed Validation for TCUs which includes Freezers, Refrigerators, Incubators and Biosafety Cabinets
- Led equipment validation projects from start to finish, including protocol development, execution, and final reporting, ensuring timely completion and adherence to budget constraints
- Trained production staff on equipment validation procedures and best practices, ensuring compliance with internal quality standards and regulatory requirements
- Managed equipment validation documentation, maintaining accurate records and ensuring traceability for audit purposes
- Executed environmental monitoring performance qualification protocols for cleanroom facilities, ensuring compliance with regulatory standards and industry best practices
- Analyzed environmental monitoring data to identify trends and potential issues, implementing corrective actions to improve cleanroom performance and maintain regulatory compliance
- Conducted risk assessments and impact analyses to determine the criticality of environmental monitoring parameters, ensuring appropriate monitoring frequency and sampling locations
- Managed environmental monitoring equipment and instrumentation, including calibration and maintenance, to ensure accurate and reliable data collection
- Prepared and presented environmental monitoring performance qualification reports to internal and external stakeholders, demonstrating compliance with regulatory requirements and best practices.
Validation Engineer
Philip Morris International
08.2022 - 01.2023
- Compiled, prepared and reviewed validation deliverables such as Installation and Operational Qualification (IOQ), Performance Qualification (PQ), and Validation Summary reports for Reverse Osmosis System, Process Water Systems, and Incoming Water Supply
- Provided technical contributions to the system design and Verification/Validation of a complex medical device from concept through commercialization and vendors input
- Executed Commissioning and Qualification protocols for manufacturing and process equipment
- Coordinated and managed the validation and qualification strategy for the equipment
- Performed Commissioning and Validation of large-scale process equipment such as Air Compressor and Reverse Osmosis Water Systems
- Monitored pre-and post-validation activities during the execution of the protocol, ensuring consistency of the validation process, and resolving discrepancies
- Additionally, provided training to operations and applicable staff on the protocol
- Focused on understanding/defining customer needs, creating product functional/performance requirements, and architecture necessary to meet those needs
- Evaluated constraints and made trade-off decisions, created system design requirements from customer inputs, and contributed to the development of module level design requirements
- Prepared Instrument Datasheets, IO Lists, Instrument List, Wiring Diagrams, and Engineering Information to support the engineering design process
- Developed engineering design packages for power and instrumentation installation in industrial plants, with a focus on controls and instrumentation engineering
- Coordinated with customers to define project scope and collect all required inputs for completing engineering design
- Led coordination efforts with offshore teams, vendors, and construction teams to deliver engineering deliverables on time and within budget
- Specified process plant instruments and gained hands-on experience in instrument selection, calibration verification, adjustments, and more
- Contributed to product safety and security risk management activities including DFMEAs
- Contributed to the identification of technical risks and mitigations, developed verification and validation plans, protocols, scripts, execution, regression, and reports
- Worked in close collaboration with offshore teams, cross functional teams of the lead engineer, project manager, and other functional team members to ensure the project/product deliverables
- Contributed in the preparation of User Requirement Specification for the Water Systems
- Performed Large Scale Performance Qualification of water samples used for production
- Evaluated and executed change control initiatives for start-up commissioning and qualification activities for manufacturing equipment
- Contributed to the development of Requirement Traceability Matrices (RTMs) for Utilities
- Compiled, Authored, and Reviewed in documenting the Validation Master Plan in accordance with FDA regulations, particularly 21 CFR 210, 211, GLP, and GMP.
Education
Bachelor of Engineering - Biotechnology
Vignan University
India01.2023
Master of Science - Biomedical Engineering
University of South Florida
Tampa, FL08.2022
Skills
- CAPA Management
- Quality Management Systems
- Validation Protocols
- Regulatory guidelines
Timeline
Principal Validation Engineer
ThermoFisher Scientific
01.2024 - 03.2024
Validation Engineer
Philip Morris International
08.2022 - 01.2023
Bachelor of Engineering - Biotechnology
Vignan University
Master of Science - Biomedical Engineering
University of South Florida
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