• Reviewed and implemented changes on P&ID for the production equipment based on the process requirement and reliability.• Worked as a key team player in team for Lipid Nano Particle (LNP) for formulation of COVID-19 vaccine.• Expertise on Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) such that the data and records comply with the principle of ALCOA.• Involved in validation, modification and implementation of recipes used during the production, cleaning in place (CIP), cleaning out of place (COP), and steam in place (SIP).• Performed investigations and implement corrective actions related to CAPAs and deviations.• Collaborated with team to develop, modify and change the process recipe, batch recipe and implement process change in the SCADA and HMI to ensure the process met the acceptance criteria.• Executed Integrated Product Run (IPR) for Covid 19 mRNA vaccine.• Highly involved in development of SOPs of the equipment and its implementation ensuring safety protocols of the equipment and associated working environment. • Highly involved in research and investigation of production issues in order to determine root cause to resolve issues in production process.• Trained for working in clean space in Grade D and Grade C along with gowning procedures• Perform process simulations and risk assessments along with providing the process documentation and operating instructions • Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA), STAT testing and drafting Remediation Plans for the project management approval after the GAP Analysis• Developed technical specifications documents necessary for generation and/or execution of CQV lifecycle documentation.• Promoting cGMP compliance within the workplace by following site cGMP procedures.• Trained for LOTO and developed Standard Operating Procedure (SOP’s) of the equipment and implementing to the production environment.

• Worked on Rockwell Automation software applications such as Plant Pax Studio 500, FactoryTalkView Site Edition, Allan Bradley Ladder Logic for troubleshooting issues related to automated systems of PLC Code, HMI and SCADA.• Coordinated with Process Engineers regarding routine and preventive maintenance work ensuring all the equipment, tanks (LNP and TFF) and facilities work safely, efficiently and reliably. • Integrated with trainers, operators, PEs, SMEs and VEs for PPQ training, IPR issues, gowning training, etc. in order to meet the standard and protocols required by the company and FDA. • Worked as an automation engineer on COVID-19 automation system development project for Mod 2.• Updated and designed Functional Specifications (FS), Design Specifications (DS) as per the non-conformances requirement and communicated the information to team leads in righteous manner.• Responsible for performing execution of Verification Testing (VT) GMP documents relating to various PLC and SCADA systems following Standard Operating Procedures (SOPs) and Good Documentation Practices (GDPs). • Issuing, drafting, reviewing, and clearing Non-Conformances (NCs) for issues and failures regarding different VTs, FS, DS, SCADA and PLC.• Implemented Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) such that the data and records comply with the principle of ALCOA.• Supported on Validation of documents creation and objectives evidence in order to support the HMI and PLC changes.• Attended daily progress meetings with team leads and managers in order to generate and develop standard operating procedures and system support. • Worked on documentation of the processes online and offline along with managing change control authoring and execution. • Responsible for organizing test runs and partnering with leads in automation and validation to ensure proper project management.