Max Liu
Melbourne,VIC
Summary
Process Validation Engineer with 4+ years of experience validating complex manufacturing processes in the medical device industry in compliance with ISO 13485 and FDA 21 CFR Part 820. Experienced in authoring and executing full validation lifecycle documentation (URS, FAT/SAT, IQ, OQ, PQ), developing and validating test methods, and performing risk assessments (PFMEA) to mitigate process risks. Proven ability to drive process improvements using data-driven approaches and statistical tools such as Minitab. Adept at cross-functional collaboration to support technology transfer, equipment commissioning, cleanroom validation, and regulatory submissions for Class I and II medical devices.
Overview
5
5
years of professional experience
Work History
Process Validation Engineer
Polynovo
Melbounre, VIC
10.2022 - Current
- Led a PMA project to optimize the glue mixing process by transitioning from manual to automated mixing, resulting in a 30% improvement in batch consistency and a 40% reduction in mixing time. Responsibilities included drafting key documentation (VPL, URS, IQ/OQ/PQ), managing validation activities, and coordinating with cross-functional teams.
- Applied DOE and conducted process capability studies to analyze and improve the foam sheets cutting process Utilized insights gained to define the URS for the new foam cutting machine and participated in FAT in Germany. The investigation identified root causes of line defects in foam sheets and informed corrective actions.
- Collaborated with R&D to support the market launch of SynPath BTM devices by optimizing cutting process parameters. Successfully expanded the product line by validating the manufacturing process for two additional BTM thicknesses (4mm & 6mm), increasing market offerings and customer options.
- Supported day-to-day operations across two manufacturing units by conducting risk assessments and CAPA investigations. Through implementing a paper printer connected to balances for weighing, resulting in a 15% increase in production efficiency and a 20% reduction in non-conformances.
- Revalidated Unit 2 facility to expand capacity from 4 to 10 operators by simulating daily production activities, conducting risk assessments to identify compatible parallel processes, and performing HVAC related tests to ensure compliance with ISO Class 8 cleanroom standards.
- Collaborated with Process Engineers to plan new equipment for the UNIT 3 facility. Conducted PFMEA for the lamination process, identifying potential failure modes, assessing their impact, and recommending mitigation strategies. Findings supported the decision to procure an automated lamination machine to reduce risk and improve process reliability."
- Developed a wet film thickness test method for in-process inspection of uncured glue sheets. Determined appropriate sampling locations and established the correlation between wet and dry thickness to define pass/fail criteria. Conducted trial tests to assess method reliability and reproducibility and used Minitab for statistical analysis.
Commissiong and Validation Engineer
Life-Space Probiotics
Melbourne, VIC
12.2020 - 10.2022
- Led cleanroom validation activities for a new ISO Class 8 facility, collaborating with design engineers, HVAC specialists, and contractors to review the User Requirement Specification (URS) for cleanroom layout, airflow patterns, HEPA filtration, pressure differentials, temperature/humidity control, and particle classification.
- Conducted IQ/OQ/PQ validation of the HVAC system, verifying installation against design drawings and specifications, conducting airflow velocity, temperature, humidity, and pressure differential tests, and validating HEPA filter integrity and room classification in accordance with ISO 14644 and GMP requirements to ensure controlled environmental conditions.
- Performed IQ/OQ/PQ of the air compressor system, verifying pressure, flow rate, and alarm functions, and ensuring compliance with ISO 8573 standards for particle, oil, and moisture content to support cleanroom utility readiness.
- Completed IQ/OQ/PQ validation of the purified water system, verifying installation per design specifications, testing flow, temperature, conductivity, and TOC during operational qualification, and conducting microbial and chemical sampling across multiple user points during performance qualification to ensure compliance with USP and ISO standards.
Education
Master of Engineering - Biomedical Engineering
University of New South Wales
Sydney, NSW01-2021
Bachelor of Engineering - Bioengineering
Xi'an Jiaotong University
CHINA07-2017
Skills
- Equipment validation: installation, operational, and performance qualification (IQ/OQ/PQ) of production and utility equipment
- Process Validation: End-to-end lifecycle execution including URS, FAT/SAT, PPQ, and CPV
- Utility Systems Validation: HVAC (airflow, pressure differentials, HEPA filters), ISO 08 Cleanrooms, Purified Water System and Compressed Air System
- Test Method Development & Validation: Designing methods for in-process and final product testing and performing TMV
- Cross-Functional Collaboration: Work closely with QA, Engineering, Manufacturing, and R&D teams to align validation with production goals
- Project Management: Coordinate validation timelines, resource planning, and deliverables across multiple stakeholders and equipment vendors
Timeline
Process Validation Engineer
Polynovo
10.2022 - Current
Commissiong and Validation Engineer
Life-Space Probiotics
12.2020 - 10.2022
Master of Engineering - Biomedical Engineering
University of New South Wales
Bachelor of Engineering - Bioengineering
Xi'an Jiaotong University
Similar Profiles
Ahmed Hassan, GAICCDAhmed Hassan, GAICCD
Chief Operations Officer at PolyNovo LtdChief Operations Officer at PolyNovo Ltd
Jyoti ShuklaJyoti Shukla
Product Specialist at Polynovo BiomaterialsProduct Specialist at Polynovo Biomaterials
Sunny NguyenSunny Nguyen
Team Projects or Group Work at High SchoolTeam Projects or Group Work at High School
Gurpreet KaurGurpreet Kaur
Client Support Professional Specialist at Australian UnityClient Support Professional Specialist at Australian Unity
Miles BalaamGundersonMiles BalaamGunderson
Gaming Attendant at First & Last HotelGaming Attendant at First & Last Hotel