Initial Process Flow, PFMEA, Control Plan (In-house & supplier) . • Be a part of tool trials, to address, analyze and motivate the team for problem solving and achieve project milestone. •Support Sales and Marketing during acquisition phase of the project (Product feasibility check, approximate budget, capacity analysis and project summary). •Participate in cost proposal development, technical discussion with marketing team. •Ensure the process validation and smooth handover of project with all the project documentation. Engineer - Projects • Sun Castings JanuaryJuly 2022 Engineer - Projects • Nahar's Engineering Ind. Pvt. Ltd. MarchDecember 2...

練 六月十月 2017 工程師 國光生物科技股份有限公司 Preparation & execution of Buffer solutions . Equipment Qualification documentations: URS, Installation/ Operation/ Performance Qualification of clean booth, cold cabinet. Preparation of GMP Standard Operation Procedure. Validation Activities:Process Validation of Module100, Clean Validation of Process Equipment, Environmental Cleaning Validation. Inspection Experiences: TFDA, EMEA, FDA 學歷嘉義大學 食品科學弘光科技大學 食品營養 技能 語言 Microsoft Office 管理與領

worked with Tier1 Glucose Meter in Germany/USA and Tier1 Endoscope in Demark to achieve total 12 products launched and success 600 times product improvement.The 12 average of products Gross profit is 20%Simplified technical quality issues by collecting problem , analyzing trouble-shooting approaches, and controlling Logistic process to keep revenue 70 million USD inFamiliar with Medical Device regulation by Quality system experience that lead team did not go long way 2.Project Management 2.1 Collaborated with 8 departments , stakeholder , supplier(Germany,Japan,China) and 1000 person Factory.It evaluated R&D resource

goals. Eager to learn with aptitude for applying new knowledge with skill and efficiency. [email protected] Work Experience JanuaryPresent Hyderabad Associate Cognizant Technology Solutions Understanding, Analyzing and Streamlining test requirements. Responsible for Quality assurance to the client and focusing on continuous improvement of the process. Attaining the quality using different tools of quality: Root Cause Analysis, Quality improvement sessions through feedbacks for error reduction. Involved in various validation processes such as MedD, QC and Direct Validation Adjudication process such as Payment posting and denying claims. Proficient in Microsoft Excel for test

Inc. AugPresent GPU System Engineer 1. New generation system development with cable routing/system configuration definition/system SPEC writing...etc. 2. AI products system performance tuning and comparison on different GPUs. 3. Study new GPU features and transfer to validation team for validation process speed up. 4. Work with production team to debugging the issues found in production line. 5. Cross-department communication for develop, test and troubleshooting. 6. Project schedule control and resource management. Senior Engineer • Compal Electronics, INC. SepAugOS

.com/in/pier-luigi-benedinib/ Work Experience JuneNov 2023 Italy Process and Project Manager Evotec Plant management - Process Improvement - New Projets ( Feseability - Basic Design) - Validation Managment - Budget Definition - HSE Managment - QA Managment - Risk Assesment - Projet Managment - People Coaching – External Supplier Management – Temas Management JuneJune 2010 Italy Process and Manufacturing Engineering GlaxoSmithKline I lead the Process Changes and the Validation effort in Pharmaceutical Science Dpt. I support the technical continuous improvement and the manufacturing process refurbishment. We have several streams, oral solid, inhalation, clean liquid, lyo production, API Plant Production, API development. AIFA and

4. Evaluate and establishing production process satisfying aseptic operation and process requirements, and developing the documents in all required aspects such as BPR. 5. Work with team to produce sterile drug products by aseptic processing and ensure production in compliance with GMP. MayApril 2022 Taipei, Taiwan Assistant Engineer Scivision Biotechnology 1. Testing, adjusting, and optimizing new machines. 2. Optimizing and improving processes. 3. Preparing and executing process, cleaning, and sterilization validations. 4. Preparing and executing equipment IQ, OQ, and PQ. 5. Planning and p...