Amruta Rupa Nemani

About Amruta Rupa Nemani

8+ years of experience in mechanical design, quality assurance, and medical device R&D.• Proficient in part and assembly design using Solid Works and AutoCAD, as well as protocol and specification authoring for new product releases.• Proficient in product design validation, design updates, bill of materials (BOM) generation, and engineering drawings for assembly.• Experienced in Design History File (DHF) remediation to achieve EU MDR (2017/745) compliance and design-related project coordination.• Proven ability in risk assessment, FMEA document management, and post-market data integration into Risk Management Files.• Contributed to NCMR and CAPA operations concerning legacy products.• Familiarity with medical regulatory standards and experience managing post-market surveillance initiatives, including EU Regulations (UDI/DPM Process, MDD, and EU-MDR Approval).• Significant expertise with ISO (13485 and 14971), FDA (21 CFR 820), EU MDR, GMP, and ASTM medical device standards, including physical and packaging testing.• Previous experience interacting with diverse clients and vendors/suppliers to complete projects on schedule.• Knowledge of FDA and ISO 13485 processes.

Experience

1. Sr Engineer i Process Development

   Amgen

   Jan 2024 — Present · New Albany, OH, US

   Enhanced understanding of validation procedures across various packaging facilities.•Supported the development and implementation of automated and semi-automated combination product assembly equipment initiatives within the Finished Drug Product (FDP) portfolio.•Led both commercial and non-commercial activities to facilitate the introduction of new products onto commercial manufacturing lines 001 and 002, including Amjevita and NextGen.•Provided process development expertise for the packaging of commercial drug products, focusing on Process Characterization, Tech Transfer, and Validation.•Developed Validation Plans/Protocols and generated Reports for both Commercial and Non-Commercial product batch engineering runs.•Collaborated with Quality, Operations, Automation, and other support functions to ensure robust and coordinated support for the manufacturing process.•Troubleshooted issues with drug product processing technologies and equipment, investigating to determine root causes.•Assisted with the characterization of B&S on L006 and with sample generation for Design Tech Transfer, Packaging, and CCI on L005.•Gathered project information and presented it to the SLT and OLT throughout the year.•Identified and implemented operational opportunities for current and new product operations.•Worked with cross-site teams to support site validation activities and provided recommendations to senior management on establishing site-specific validation processes.•Provided technical operations support for the continuous improvement (CI) of device assembly and packaging line capacity and performance, as well as technical improvement projects.•Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the site by analyzing, designing, and implementing manufacturing and business process improvements.

Education

• Jawaharlal Nehru Technological University

  Bachelor of Technology - BTech, Mechanical Engineering

• Trine University

  Master of Business Administration - MBA, Business Administration and Management, General

• The University of Texas at Arlington

  Master of Science - MS, Mechanical Engineering