Juan Uvina

About Juan Uvina

A successful Maintenance professional with extensive experience in the pharmaceutical industry. Proven track record with excellent leadership & communication skills to develop strong working relationships with internal customers. Focused on Organizational Effectiveness with demonstrated ability to recruit, train and develop versatile Maintenance staff for start-up and ongoing maintenance troubleshooting, repairs as well as corrective and preventive maintenance work orders. Strength & experience providing technical support of Production Operations & QC Labs.Expertise includes:• Facilities & Critical Utilities Maintenanceo Water For Injection (WFI) generation, storage, and distribution- use heat exchangers to cool down (85 degrees C) hot loop for Production to use WFI for Compoundingo Reverse Osmosis (RO) generation, storage & distributiono City Water Pre-treatment systemso Clean Steam generators & distributiono Chilled Water Systemso Cooling Towers (water conservation measures- installed flow meters at multiple discharge points)o HVAC (control Temp, Humidity & Directional Air Flow)o Freon Recovery EPA universal certifiedo HEPA Filter Testing/Certificationo Oil Free Compressed Air (OFCA)o Sitewide GFI testing• cGMP & GxP sustained compliance (SOPs, PMs, Training & Change Control)• ISO-5 Sterile Filling Suites –Continuous Particle Measuring Systems (CPMS)• Organizational Development /Team Building (Technical “lunch and learns”)

Experience

1. Sr Consultant

   Azzur Group

   Jun 2019 — Present · Irvine, CA, US

   Manager, FUSE, Facilities Maintenance and Critical systems at Azzur Group.A successful Maintenance professional with extensive experience in the pharmaceutical industry. Proven track record with excellent leadership and communication skills to develop strong working relationships with internal customers. Focused on organizational effectiveness with a demonstrated ability to recruit, train, and develop versatile Maintenance staff for startup and ongoing maintenance troubleshooting, repairs, and corrective and preventive maintenance work orders. Strength and experience providing technical support of Production Operations and QC Labs. Expertise includes:• Facilities and Critical Utilities Maintenance:• Water for Injection (WFI) Generation, Storage, and Distribution – Used Heat Exchangers to Cool Down (85°C) Hot Loop for Production to Use WFI for Compounding• Reverse Osmosis (RO) Generation, Storage, and Distribution• City Water Pre-Treatment Systems• Clean Steam Generators and Distribution• Chilled Water Systems• Cooling Towers (Water Conservation Measures – Installed Flow Meters at Multiple Discharge Points)• HVAC (Control Temperature, Humidity, and Directional Air Flow)• Freon Recovery EPA Universal Certified• HEPA Filter Testing/Certification• Oil Free Compressed Air (OFCA)• Site wide GFI Testing• GxP Sustained Compliance (SOPs, PMs,Training, and Change Control)• ISO-5 Sterile Filling Suites – Continuous Particle Measuring Systems (CPMS)• Organizational Development/Team Building (Technical “Lunch and Learns”)

Skills

• Iso 13485
• Verification and Validation (V&V)
• Standard Operating Procedure (Sop)
• Spc
• Biotechnology
• Regulatory Affairs
• Dissolution
• Quality System
• V&V
• Validation
• Technology Transfer
• Hvac
• Hplc
• U.s. Title 21 Cfr Part 11 Regulation
• Quality Assurance
• Formulation
• Biopharmaceuticals
• Regulatory Requirements
• Chromatography
• Gamp
• Aseptic Technique
• Lims
• Gmp
• Change Control
• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Glp
• Gxp
• Aseptic Processing
• Trackwise
• Corrective and Preventive Action (Capa)
• Pharmaceutical Industry
• Sop
• Fda
• Cleaning Validation
• Capa
• Laboratory Information Management System (Lims)
• 21 Cfr Part 11