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Pramod Patla - Validation Engineer

[email protected]

Location: Rochester, New York, USA

Relocation: Yes

Visa: H1B

Pramod Patla Validation Engineer 3613556200 [email protected] Rochester, NY Yes H1B Professional summary: Experienced Quality and Validation professional with over 5 years of experience in diverse Engineering arenas. Quality Engineering experience includes supporting Research and Development (R&D), New Product Development (NPD), New Product Implementation (NPI), Leading Transfer Projects and Supplier Qualification activities in compliance with regulatory requirements in line to meet the deadlines as planned. Validation Engineering experience includes Leading and/or supporting Design Validation, Validation of Manufacturing Equipment's like Filling, Coating, Assembly, Packaging, and Injection molding Equipment's. Facilities Validation, Utilities Validation and Process Commissioning activities. I am highly goal driven, good team player and balanced leader with decision making ability. Very passionate towards finishing the projects on timely manners, always open to learning new things and adopting to the changes. Technical expertise in Continuous Improvements and manufacturing operations management systems for the end-to-end visibility of the R&D, Process optimization, production, quality, supplier quality, inventory, calibration, and maintenance operations. Extensive Knowledge in Food and Drug Administration (FDA) regulations 21 CFR Part 11, 210, 211, 820, 821, ISO standards 13485, 14644, 14791(Safety and Risk Management), GAMP, cGxP and EU regulations. TECHNICAL SKILLS: Regulatory FDA: 21 CFR part 11, 210,820, 821, 860. ISO: 13485, 14971, 14644. EUMDD and EUMDR. PLM s Agile, Windchill, SAP NetWeaver and Business Client, Veeva Vault. QMS IQMS, Flex QMS, SAP, Veeva Vault. Other s R&D, Product Development, Design Transfer, IQ, OQ, PQ, CTQ s, Root Cause Analysis, CAPA, NC s, FMEA, Microsoft Office (Excel, Power point, Word, Outlook, Microsoft Visio). WORK EXPERIENCE: Sr. Quality/Validation Engineer Jan. 2023 Present West Pharmaceutical services - Phoenix, Arizona Responsible for working with the Cross - function team in NPI to ensure that process and products are continuously, efficiently meeting customer requirements, FDA guidelines 21 CFR part 820, ISO-13485, EU-MDR and GxP systems. Responsible for updating the pFMEA based on the updates made to the production process for existing projects and authoring pFMEA for New Projects following ISO-14971 standards. Reviewing and approving the Validation Protocols (FAT, SAT, IQ, OQ, PQ), deviation and Summary reports. Lead the Corrective Actions and Preventive Action (CAPA), Root Cause Analysis (RCA) and oversee the implementation of changes related to CAPA. Responsible for managing the CAPA team in terms of assigning tasks to cross functionality team and following up the updates. Verified the changes made to existing procedures and measure the effectiveness of the Corrective actions. Leading the migration of Quality control and production related documentation for the transfer project. R&D Quality/Validation Engineer Mar. 2022 Dec. 2022 QuidelOrtho - Rochester, New York Responsible for working with the Cross - function team in R&D to ensure that QMS documentation are accurate, complete, and efficient following internal, FDA guidelines 21 CFR part 820, ISO-13485, EU-MDR and GxP systems. Responsible for creating Change Request (CR), Change Notices (CN) related the product, process, and document updates. Update the FMEA to match with the updates made to the product and process. Reviewing and approving the Validation Protocols (FAT, SAT, IQ, OQ, PQ), deviation and Summary reports. Author, review and approve the Standard Operating Procedures (SOP), Work Instructions, for new testing process. Design and author the Sampling plan and sampling plan rational with the help of the R&D scientist for In-process testing. Review and approve the design of the fixtures. Lead the Corrective Actions and Preventive Action (CAPA), Root Cause Analysis (RCA) and oversee the implementation of changes related to CAPA. Responsible for verifying the Preventive actions. Involve and resolve discrepancies related to the everyday production like non-conformances. Validation Engineering Lead July 2021 Mar. 2022 Flextronics (Flex) - West Columbia, South Carolina Lead a team of 5 Validation Engineers to Commission and Validate the Facilities, Utilities, Equipment and Process operations in a timely manner to meet the deadlines as planned. Authored the Master Validation Plan (MVP) and traceability Matrix for the project. Responsible for qualifications and maintenance of Cleanrooms and utilities to meet with the ISO class7 and 8 requirements per ISO- 14644 standards. Authored the qualification and validation documents like Validation plan, Installation Qualification, Operational Qualification, Performance Qualification for facilities and utilities. Authored Test Protocols to perform heat map studies and Air flow in the facility for the placement of Continually monitoring sensors. Reviewed and approved qualification and validation documents like Installation Qualification, Operational Qualification, Performance Qualification, and Test Method Validations for equipment and process operations following internal, FDA guidelines 21 CFR part 820, ISO-13485 and GxP systems. Reviewed and approved the Qualification documents for Design Qualification (DQ), Design Transfer (DT), Factory Acceptance testing (FAT) and Site Acceptance testing (SAT). Plan, perform and oversee inspections, Sampling size for the Validation runs. Reviewing records and performing real-time review during validation of manufacturing operations and supporting documentation for completeness, accuracy, and compliance. Author, review and address the deviations associated with different issues across during the Validations. Quality/Validation Engineer Nov. 2019 July 2021 Phillips Medisize a Molex Company - Hudson, Wisconsin Part of remediation and Continuous Improvement projects following internal, FDA guidelines 21 CFR part 820, ISO-13485 and GxP systems. Review and approve the Stock Keeping Units (SKU s) setup and Bill of Material (BOM) updates for day-to-day production activities. Involved in Lean Manufacturing Group and increased the productivity by 20% on each production line. Responsible for updating the pFMEA based on the updates made to the production process for existing projects and authoring pFMEA for New Projects following ISO-14971 standards. Responsible for providing quality support for regular production activities and resolve discrepancies related to the product like Non-Conformances (NCMR s), Deviations, Corrective Action and Preventive Action (CAPA s) and author the Quality Technical Documentation (QTD s). Perform gap analysis in production and update the quality documents as required. Author, review and approved SOP s, work instructions, forms, and memos in a change management software (CMS). Responsible for New Supplier Qualification and updating the Approved supplier List (ASL). Responsible for working with supplier about the shipping related non conformances, ranking and Issuing Supplier Corrective Actions Requests (SCAR) based on requirements. Responsible for requirements gathering for projects with the vendor and cross-functional teams. Responsible for qualification (Validation) of Equipment and production process. Manufacturing Quality/ Validation Engineer June 2018 Nov. 2019 Thermo Fisher Scientific - Millersburg, Pennsylvania Responsible for executing the Validation Protocols (IQ, OQ and PQ). Assisting with deviation, root cause analysis and finding the resolution for the deviations. Setup Calibration and Maintenance Cycles for the Manufacturing Equipment. Plan and perform regular production inspection activities and testing of products to ensure the quality deliverable are met during the Validation executions. Writing, reviewing, updating, and redlining procedures following Good Documentation Practices (GDP). Responsible for performing Design of Experiments (DOE s) to get operating parameters. Perform GAP analysis, requirements gathering for projects with the vendor and cross-functional teams. Review records and performing real-time review during validation of manufacturing operations and supporting documentation for completeness, accuracy, and compliance. Performs On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing, documentation in real-time, and resolving issues that occur during manufacturing. Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices. Involvement and resolving discrepancies related to the product like non-conformance's, deviations, CAPA, etc., Elaborate on the procedures of sampling and guidelines for the collection and reporting of quality data. EDUCATION: M.S in Industrial Managements and Technology, Texas A&M University -Kingsville, USA Dec. 2018 B.E in Mechanical Engineering, Osmania University, India May 2016 Keywords: access management rlang New York North Carolina