Equipment/Systems/facilities implementation: • Led cross-functional teams to successfully commission and qualify pharmaceutical manufacturing equipment, utilities, and facilities, managing projects ensuring regulatory compliance and seamless production integration.• Assisted in developing pre-project approval documents, including project charter, management plan, kick start, estimate, and milestone schedules.• Developed project proposals, managed budgets, and monitored KPIs to achieve strategic objectives.• Managed contractors/vendors to define outcomes, coordinate efforts, establish metrics, and adapt to achieve goals.• Authored/executed/reviewed/approved system life cycle documents per SOPs and regulatory guidelines.• Identified and implemented continuous improvement projects resulting in efficiency, safety, and quality enhancements.• Provided technical expertise as an area SME, presenting to Regulatory Agencies when necessary, and ensuring compliance with cGMP, regulatory requirements, and company standards.• Provided technical expertise to define approaches and execution of applicable system validation activities per cGMP, cGXP, CFR 21 Parts, 11, 210, and 211, EU Annex 11, and other applicable regulations, procedures, and industry guidance.Software Deployment:• Implemented Kneat software, reducing validation workload by 70% and new equipment implementation timelines by 40%.• Owned Change control for the implementation of system upgrades. • Standardized validation processes across the network in collaboration with corporate senior management.Worked on the following Equipment: - Environmental Monitoring System, - Utilities Monitoring System and Utilities (WFI loop implementation, RO implementation)- Vials/ Syringe Filling lines (Traditional and SUS), - Secondary packaging lines- Sterilization equipment (Autoclaves, VHP Chambers, Component Processing)- Controlled Temperature Units (Freezers, Cold Rooms) and Temperature Monitoring system

- Capital Projects Support: Contributed to control systems projects within capital projects, delivering technical expertise for all manufacturing equipment and lab instruments.- Accelerated time-to-market: Spearheaded the implementation of COVID vaccine production lines, achieving market readiness 25% faster than industry norms by utilizing Agile frameworks to adapt to rapidly changing requirements.- Quality Enhancement: Led root cause analysis and CAPA implementations, resulting in a 50% reduction in deviations.- Optimized resource allocation: Collaborated on project planning and execution, leading to a 20% reduction in project costs and a 15% increase in throughput through efficient resource management and process optimization.- Project Management: Developed and executed project plans, budgets, and schedules, ensuring alignment with strategic objectives and regulatory requirements.- Risk Management: Conducted Business and Quality Risk Assessments (FMEA), mitigating potential project risks and ensuring compliance with industry standards.- System Validation: Authored, executed, reviewed, and approved system/equipment validation life cycle documents.- Continuous Improvement: Implemented ISPE guidelines for periodic review studies and validation deviation Worked on the following Equipment/systems : - Environmental Monitoring System, - Utilities Monitoring System and Utilities (New WFI loop implementation, RO implementation)- Vials/ Carpujects /Syringe Filling lines (Traditional and SUS), - Vials and MDCP product packaging lines- Sterilization equipment (Autoclaves, VHP Chambers, Component Processing Systems)- Controlled Temperature Units (Freezers, Cold Rooms) and Temperature Monitoring software

• Coordinated/oversaw the development of new processes or troubleshoot existing ones. • Scheduled and executed validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines for manufacturing equipments and lab instruments.• Coordinated and communicated all testing with affected functional groups and evaluated test results.• Executed equipment, facility, utility, and computer system, Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyzing data, and composing a final report.• Oversaw and assisted Engineers and/or Technicians with their assigned projects.• Participated in the presentation of results to the Regulatory Agency when necessary.• Provided technical expertise to define approaches and execution of system validation activities by cGMP, cGXP, CFR 21 Parts, 11, 210, and 211, EU Annex 11, ICH Q7, Q8, and Q9, and other applicable regulations, procedures, and industry guidance.• Thorough understanding of risk-based validation for computerized systems, industry standards, and best practices for computer system validation, such as, but not limited to GAMP 5 and ASTM E2500• Participated in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.• Participated in teams assembled to specify, install, validate, troubleshoot, and maintain systems and equipment.- Conducted Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).

- Increased throughput: Designed and implemented advanced automation solutions, resulting in a 50% increase in production efficiency and a 30% reduction in equipment downtime through real-time data analytics.- Enhanced operational readiness: Developed and standardized automation-related documentation and SOPs, improving operational efficiency by 25% and ensuring compliance with industry regulations.- Engineering and Automation Support: Provided engineering and automation support related to the installation, commissioning, testing, qualification, operation, and maintenance of process and automated equipment/ systems within the manufacturing facility.- Design and Qualification: Supported the design and qualification of improvements, changes, or upgrades to equipment/systems as needed.- cGMP Practices: working knowledge of cGMP practices and industry regulations.- Shutdown Activities: Participated in shutdown activities by preparing commissioning test plans (CTP), decommissioning checklists, and executing the protocols.- Troubleshooting and Maintenance: Diagnosed and resolved issues with automated systems to ensure minimal downtime and maintain continuous production.- Training and Support: Provided training and support to operational staff on the use and maintenance of automated systems.- Compliance: Ensured all automation activities complied with regulatory standards and internal policies.

Research Experience:Worked with Dr. Andrea Da Costa on Membrane Bioreactors (MBRs) with a wide range of applications. Focused on addressing the challenges of MBRs, particularly on understanding energy consumption issues and opportunities to optimize and reduce costs, thereby improving the commercial viability of MBRs. Conducted literature reviews and techno-economic analysis of MBRs, with research impacting wastewater treatment industries, pulp and paper industry, and more.Laboratory Experience:- Followed GLP (Good Laboratory Practices) to conduct routine physical, chemical, and instrumental analysis.- Conducted R&D, designed, and performed experiments for alkaline leaching using ASTM standards.- Developed efficient methods to remove phosphorus from iron ore and worked on the startup of a lab-scale plant.- Implemented and developed SOPs and ICH guidelines for lab analysis and facilitated periodic laboratory audits.- Prepared, conducted, documented, and presented results and data of routine analytical testing in accordance with GLP.Projects Worked on with Advisor Dr. Timothy Eisele:- Recovery of Lead from Recycling Slag, RSR Corporation- Phosphorous Removal from Iron Ore, ArcelorMittal Group

- Agile Environment: Worked in an Agile specialty chemical manufacturing environment.- Team Coordination: Coordinated with the process engineering team for process flow design and plant setup, and assisted with troubleshooting when needed.- Documentation: Developed PFDs and evaluated P&IDs for plant setup; OSHA 40-hour safety trained.- Management of Change: Prepared punch lists for periodic product changes to manage changes (MOC).- Unit Operations: Learned and handled various unit operations in progress for product production.- Safety Management: Followed Process Safety Management regulations and prepared SOPs for handling HAZOP.- Process Engineering: Assisted in developing PFDs and evaluating P&IDs for various intermediates used in the fertilizer industry.- Process Hazard Analysis: Participated in a panel for Process Hazard Analysis, reviewed SOPs, and suggested appropriate changes.

Objective: To improve the steam economy of Multiple Effect Evaporator by developing various cost-effective techniques.• Worked on Material and Energy Balance for different schemes. • Experimenting for the change in boiling point of sodium sulfate solution at atmospheric pressure and in vacuum.• Using Excel provided Analytical solutions for different schemes.Impact: Implemented backward feeding scheme for the MEE in plant improved the steam economy from 1.1 to 1.4.