Pravalika K Email & Phone Number

New Jersey, United States

• Led process validation activities for various pharmaceutical manufacturing processes, ensuring compliance with FDA regulations and cGMP standards.• Successfully completed the full life cycle implementation of Manufacturing Execution Systems (MES) using Camstar (Siemens Opcenter) and GE Profic• Managed and executed temperature mapping studies for controlled environments and ensured that all equipment met validation requirements.• Collaborated with cross-functional teams to develop and maintain validation master plans, ensuring alignment with corporate quality standards and regulatory requirements.• Provided technical support and training to production and quality assurance teams, ensuring proper execution of validation protocols and adherence to SOPs.• Conducted a gap analysis of existing validation protocols, identifying critical areas for improvement and aligning them with current regulatory guidelines and best practices.• Proficient in Camstar (Siemens Opcenter) for MES, utilizing the platform to streamline manufacturing operations and enhance process control.• Implemented a risk-based approach to process validation, focusing on critical quality attributes (CQAs) and critical process parameters (CPPs) to optimize the validation effort.• Executed stress testing and stability studies for new formulations, contributing to the development of robust shelf-life projections.• Strong understanding of COA, CIO, and MIO interface connectivity, facilitating robust data exchange between MES and external systems.• Spearheaded the definition and implementation of the Factory Model within MES, aligning the system with the manufacturing workflow to enhance productivity and traceability.• Collaborated with the Quality Control department to develop and validate new analytical methods, ensuring reliable testing of in-process materials and final products.• Identified and mitigated project risks by implementing corrective measures during the testing phase.

Senior Process Validation Engineer Boston Scientific

• Author of Validation Lifecycle documents such as the Validation Master Plan, Computer System Validation Master Plan, User Requirement Specifications, Factory Acceptance Tests, Site Acceptance Tests, Installation Qualifications, Operational Qualifications, Performance Qualifications, and Process Validation protocols, as well as change controls, risk assessments, component criticality assessments and the traceability matrix.• Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks including PFMEA updates and escalation of Design Document changes as needed.• Extensive hands-on experience in Commissioning and Qualification (URS, FAT, IQ, OQ & PQ) of custom-built equipment such as Liquid Fillers, Tray Loaders, Filling Equipment, Vial Washers, Autoclave, Incubators, Temperature Controlled Units including Refrigerators, Cold Rooms and Freezers, Incubators and Validation of various other equipment including Process Vessels, Kill tanks, Blenders, Packaging, Bioreactors Coating Machines Packaging lines and other supporting systems.• Defined test plans and methodology to ensure all aspects of design verification and validation (V&V) were covered.• Provided Validation consulting servicesduring thegeneration and execution of qualification, validation and remediation protocols and reports. Reviewedand approved Commissioning, IQ, OQ and PQ protocols, reports, and related documentation .• Completed life cycle implementation of Manufacturing Execution Systems (MES) on COTS products like Camstar Enterprise Platform and GE Proficy, including system upgrades.• Collaborated with cross-functional teams, including Quality, Production, and IT, to ensure successful MES implementation and integration.• Computerized Systems (MES, SCADA, PLC), Equipment, Quality Control Laboratory, Utilities, proficiency in process plant automation, utilities, industrial networks, and gas systems.

Washington Dc-Baltimore Area

• Responsible for leading and executing validation activities in a fast-paced cGMP manufacturing environment: review and approve executed qualification /validation documents, for facilities, processes, and equipment.• Performed IQ, OQ, PQ and TMV for processes in manufacturing.• Prepare the Operational Qualification for Camstar MESSystem, and execute the OQ as part of Validation of the Camstar MES System.• Wrote and executed requalification of VHP Sterilization processes in aseptic manufacturing of CTMs to ensure.• compliance with ISO and Sanofi Corporate requirements for validation.• Authored process validations for two fill lines involving the aseptic processes of Gruenberg ovens and Cozzoli vial fillers,all with Allen-Bradley PLCs.• Assisted in the execution of OQ protocols for VHP-decontamination of, and environmental monitoring (viable and non-viable) of class 100 barrier isolators.

Boston, Massachusetts, United States

• • Ensured protocols, verifications, validation plans, and summary reports generated during validation/qualification activities are stored according to procedure.• Drafted SOPs, batch records, and line templates.• Worked with cross functional teams (Facilities, Manufacturing, Quality Control etc.) to perform multiple VHP Performance Verification runs till the optimal surface sanitization was achieved.• Participated in developing and updating Equipment and Software validation protocols and change controls.• Identified Equipment and Equipment validation quality critical parameters and updated the specifications.• Wrote, updated, and revised the production batch and Equipment validation reports.• Coordinated and supported the execution of Equipment validation activities.• Reviewed and approved the test methods and sampling plans for Equipment validation.• Participated in technology transfer activities.• Supported in writing master validation plan for Equipment validation activities.• Involved in writing deviations and performing Effectiveness checks.