Jun Gao
Union City,CA
Summary
- Expert in Equipment/Facility/Utilities Commissioning and Qualification –- Use risk-based and integrated commission and qualification approach with current best-practiced Quality Risk Management system; Author and review User Requirement Specification, Design Qualification, Risk Assessment, Validation Plan/Protocol; Execute equipment/systems start-up, commission and qualification activities of bioprocess equipment, HVAC and utilities systems; Perform data integrity analysis and gap assessment for GMP data issues within equipment/system; Expert in lifecycle management process Expert in Quality System/Standards, Risk Management and cGMP practices/standards — Conduct/Lead deviations/CAPA investigation and root cause analysis; Expert in change control process and impact assessment; Participated in EMA, FDA, and clients’ audits Participated in several multi-millions’ capital projects of cGMP facilities start-ups and modifications –Work with multi-functional groups to meet challenging timeline and project goals; Supervise and guide contractors in project and daily activities; Willing to listen and work in various functional groups environment; Good at “Problem-Solving”. Expert in Sterilization and Cleaning Validation — Develop Steam and VHP sterilization methods and strategies for autoclaves and isolator microbiological qualification; Develop cleaning validation methods, strategy, and family grouping; Develop and execute Clean-in-place (CIP) cycle development and cleaning validation of bioprocess equipment.
Overview
22
22
years of professional experience
Work History
Principal Validation Engineer
Grifols Diagnostics
05.2023 - Current
- Support Cleaning activities in Bulk Manufacturing Facility, including cleaning verification/ validation, and routine monitoring
- Support Process Validation of commercial product PPQ run, New Product Introduction.
Sr. Quality Engineer
Boehringer Ingelheim
02.2018 - 04.2023
- Use risk-based and integrated method to equipment commission and qualification for large Process Equipment (bioreactors, centrifuge, viral filtration skids, chromatography skids, tanks), Computerized Systems (DeltaV PCS and SCADA), Clean Utilities, HVAC and Clean Room Qualification; Perform Data integrity and GAP analysis on systems; Authored various qualification documents
- Lead deviation investigation and root cause analysis for clinical and commercial campaigns
- Actively participated in large project planning; Deliver completion of the projects on time and on budgets to meet Manufacturing schedule; Work with multiple functional groups to meet project deadlines and shifting priorities; Was awarded “Top Performer” the last 2 years
- Participated in Change Control Review Board; Provided Change Control Impact Assessment and CC actions closure activities
- Participated in site-wide process improvement projects and provide SOP revisions and update to align with overall site-goals
- Lead and Manage contractors to complete commission and qualification activities in challenging timeline and budget; Provided technical guidance and ideas to other new members of the team
- Participated in EMA, FDA and Clients Audit as a SME.
Senior Validation Engineer
Total Validation Services Inc
05.2014 - 01.2018
- Led commission and qualification (IOQ and PQ) activities for clean utilities (purified water system) and Large process equipment, including SKAN Sterility Isolators, parts washer, and depyrogenation oven; Authored commission/ qualification protocols, reports, and trace matrix; Led commission and qualification of Temperature Control Units, including -70C, -20C freezers, refrigerators, and incubator chambers
- Provided technical support for data integrity assessment, PM activities, QC method qualification, and new SOPs creation.
- Led a new Cell and Gene Medicine Facility’s HVAC and utilities commission and qualification activities Authored commission and qualification protocols and reports for utilities and HVAC systems.
- Led qualification activities for SIP of Bioreactors, including 100L, 5,000L and 25,000L, and Tanks, Media, Buffer and Product Pool tanks
- Executed clean validation of bioreactors, tanks, and purification skids (viral filtration, column packing and chromatography skids).
Senior Process Engineer
Advent Engineering Services Inc.
11.2010 - 05.2014
- Implement mechanical changes to bioreactors, commission and qualification Executed cleaning verification of a UF/DF skid.
- Supported and executed a new CIP skid installation and IOQ
- Executed automation OQ testing of CIP and SIP sequences, with experience in Delta V control of the CIP skids and other process equipment, including filler, formulation/buffer tanks, and portable tanks
- Performed the SIP and CIP cycles development, recipe/program debugging, and execution of the SIP and CIP validation
- Executed in cleaning validation of fillers, and tanks (buffer, formulation, and portable tanks).
- Commission/qualification of a CIP skid and performed CIP cycle development
- Authored the revision of the validation project plan for the retrofit project, and cleaning validation protocols
- Execute cleaning validation for bulk process tanks, including the spray coverage, and cycle parameters optimization
- Commission and IOPQ of small parts cleaning in a new Parts Washer.
Pharmaceutical Engineer II
Hyde Engineering & Consulting
08.2005 - 08.2010
- Commission and qualification of clean utilities systems (including process air, water-for-injection, and clean steam), and various bioprocess systems, including fillers, vial washer, buffer tanks, and CIP skids;
- Commission and qualification of clean utilities and bioprocess systems (including bioreactors, media, and buffer tanks)
- Authored and reviewed process, cleaning validation summary reports; Executed cleaning validation of clean-out-place (COP) skid, and parts washer.
Senior Research Associate
NOBEX Corporation
01.2002 - 01.2004
- Process development and scaling up of HPLC purification of small molecule proteins.
Education
Master of Science - Chemical Engineering
North Carolina State University
Raleigh, NC01.2001
Bachelor of Science - Chemical Engineering
University of Florida
Gainesville01.1996
Skills
- Effective Communication
- Equipment Qualification
- CAPA Management
- Data Integrity
- Change Control
- FDA regulations
- Computer system validation
- Validation Testing
- Critical Thinking
- Change Control Management
- Audit processes
- Quality Management Systems
Timeline
Principal Validation Engineer
Grifols Diagnostics
05.2023 - Current
Sr. Quality Engineer
Boehringer Ingelheim
02.2018 - 04.2023
Senior Validation Engineer
Total Validation Services Inc
05.2014 - 01.2018
Senior Process Engineer
Advent Engineering Services Inc.
11.2010 - 05.2014
Pharmaceutical Engineer II
Hyde Engineering & Consulting
08.2005 - 08.2010
Senior Research Associate
NOBEX Corporation
01.2002 - 01.2004
Master of Science - Chemical Engineering
North Carolina State University
Bachelor of Science - Chemical Engineering
University of Florida