Edwin Feliciano

About Edwin Feliciano

Director of Facilities, and Engineering with an extensive and diverse experience in the Bio Pharma, Medical Device and 503B cGMP industries, where have delivered complex and high-value capital projects that improved the quality, efficiency, and safety of the products and processes.Most recently at Leiters Health, managed a $9M+ site capital project portfolio that involved capacity expansion, process improvement, equipment commissioning and qualification, facilities/utilities upgrades and cleanroom space construction for an aseptic filling operation. Directed a 30+ engineering organization including engineers, maintenance technicians, and validation specialists who ensure the compliance and reliability of the IV bags, syringes, and vials aseptic filling operation. My mission is to leverage my engineering expertise and business acumen to drive innovation and excellence in the healthcare sector.Professional Skills- Quality and Regulatory Management: Change Control, CAPA, FDA cGMP guidelines/audits, SOPs governance, Commissioning, Qualification and Validation, Risk Management (FMEA), QMS (Trackwise, Master Control)- Capital Project Management: Strategic Planning and Execution - Lifecycle Asset Management: BMS, CMMS (JDE, BRAM, SAP), Metrology, GxP Equipment Preventive Maintenance, Reliability and Spare Part MRO- Resource Management: Hiring, Recruiting, Staffing and Development- Product and Process development: MSAT, NPI, DfM- Experience with modern lean manufacture techniques - Kaizen, 5S, Structured Problem Solving, Decision Making, Value Stream Mapping - OpEx/CapEx budgeting management- External Suppliers and Service Contract Management- Automation Equipment- Manufacturing Improvement (DMAIC)- Results Driven Leadership and KPI Management- Computer Proficiency: Microsoft Office including Microsoft Project, and AutoCad- Prioritization and Strategic Time Management in Fast Pace Environment- Environmental Health and Safety (EHS)- Experienced in Bio Pharma processing: Aseptic Processing, Sterile liquid filling, VHP systems, Formulation/Mixing, Process Control Automation (Delta V), CIP skids, Utilities systems (HVAC, WFI, Power distribution, Cooling Tower, P & ID, Compress air, Boilers)- Experienced in medical device manufacturing: Plastics Material Joining (Ultrasonic, Hot bar, induction welding, UV boding), Packaging Equipment (FFS, Bag Sealers, Case Sealers, Printing and Labeling Systems), Assembly Robotics, Inline Product Inspection Techniques (Vision Systems, Leak detector, Particle Matter), Extrusion, Molding and Terminal Sterilization

Experience

1. Director Process Improvement Engineering

   Terumo Blood and Cell Technologies

   Sep 2024 — Present · Lakewood, CO, US

Education

• University of Puerto Rico-Mayaguez

  Bachelor of Science (BS), Mechanical Engineering

• Universidad del Turabo

  Master of Business Administration (MBA), Business Administration and Management

Skills

• Minitab
• 21 Cfr Part 11
• Dmaic
• Design for Manufacturing
• Change Control
• 21 Cfr
• Gmp
• Quality System
• V&V
• Root Cause Analysis
• Fda Gmp
• Fmea
• Validation
• Cross-Functional Team Leadership
• Iso 14971
• R&D
• Design of Experiments
• Automation
• Iso
• Pharmaceutical Industry
• Fda
• Biomedical Engineering
• Medical Devices
• Capa
• Spc
• Six Sigma
• Quality Auditing
• Aseptic Processing
• Iso 13485
• Design Control