Engineer (Cleanroom and Sterilization)

ABOUT VINUNIVERSITY
VinUniversity (VinUni) is Vietnam’s first private, not-for-profit university established to international standards, with the vision of becoming one of the world’s top 100 universities. Guided by its core values (EXCEL) of Empathy, Creativity, Leadership Mindset, Exceptional Capability, and Entrepreneurial Spirit, VinUni develops talent equipped to create meaningful impact in Vietnam and globally.
Founded by Vingroup, one of Asia’s largest private conglomerates, VinUni benefits from a dynamic ecosystem spanning Industrials & Technology, Real Estate & Services, Infrastructure, Green Energy, Culture, and Social Enterprises. This ecosystem provides unique opportunities for collaboration and innovation through leading organizations such as VinFast, Vinpearl, Vinmec, Vinschool, and Vinhomes, as well as a vibrant entrepreneurial network including VinVentures, VinMotion, VinRobotics, VinSpace, and VinEnergo, etc.
VinUni comprises four colleges: the College of Arts and Sciences, the College of Business and Management, the College of Engineering and Computer Science, and the College of Health Sciences. The University has established strategic partnerships with Cornell University, the University of Pennsylvania and Nanyang Technological University to advance excellence in education, research, and innovation.
In 2024, VinUni became the youngest and fastest university globally to achieve QS 5 Stars, earning the highest rating in nine categories: Global Engagement, Good Governance, Program Strength, Academic Development, Teaching, Employability, Facilities, Arts, and Social Impact. The University was also appointed by UNESCO as the first and only UNESCO Chair University, focusing on Environmental Leadership, Cultural Heritage, and Biodiversity.
As a rapidly growing research-intensive university, VinUni is investing in world-class talent, research centers, and cutting-edge facilities to drive breakthroughs in Artificial Intelligence and Machine Learning, Data Science, Environmental Intelligence, Innovations in Health Sciences, Policy Development, and Sustainable Societies.

ABOUT THE POSITION
The Institute of 3D Technology in Medicine (VI3D) is being established at VinUniversity on the foundation of the VinUni 3D Technology in Medicine Center (3D Lab), working closely with Vinmec Healthcare System. Since 2022 the 3D Lab has delivered more than 1,300 personalized cases for 18 hospitals, including patient-specific surgical instruments, anatomical models, cranial implant molds and customized titanium implants, under a quality management system certified to ISO 9001 and ISO 13485. 3D technology in medicine is listed among Vietnam's national strategic technologies, and VI3D is set to deliver national strategic technology tasks on personalized 3D-printed medical devices under the Ministry of Health for 2026–2030, spanning design, polymer and metal additive manufacturing, clinical trials, national standards and commercialization.
Reporting to the Chief Operating Officer, who concurrently heads the Operations, Quality and Product Department, the Engineer operates VI3D's cleanroom area and the final stages of implants and personalized instruments: final cleaning, environmental control, packaging, labelling, dispatch for sterilization and lot sterilization records.
This stage decides whether a product may be used in a patient, and its records are mandatory evidence for the quality management system and registration dossiers.
KEY RESPONSIBILITIES

• Cleanroom operation: Operate the cleanroom in line with ISO 14644: gowning, cleaning and disinfection schedules, environmental monitoring (particles, pressure differential, temperature, humidity, microbiological), and handling of deviations.

• Final cleaning: Perform final cleaning of titanium implants and polymer instruments, including residual powder removal and ultrasonic cleaning; support cleaning validation and residue testing.

• Packaging and labelling: Package and label products in line with ISO 11607 and applicable labelling rules, including labelling of investigational devices as required by Decree 98/2021/ND-CP; support packaging and seal integrity validation.

• Sterilization: Coordinate sterilization with Vinmec central sterile services or contracted providers by the appropriate method (e.g., moist heat under ISO 17665, ethylene oxide under ISO 11135, vaporized hydrogen peroxide under ISO 22441); keep sterilization records and indicators per lot.

• Lot release records: Complete batch records and traceability in the quality system; coordinate with QA for product release.

• Equipment: Maintain cleanroom and packaging equipment records (ultrasonic cleaners, sealers, HEPA filtration).

• Procedures and training: Contribute to process validations and SOPs; train staff on cleanroom practice.
  KEY SELECTION CRITERIA
  EDUCATION AND EXPERIENCE

• Bachelor's degree in Biomedical Engineering, Chemical Engineering, Microbiology, Pharmacy, Nursing or a related field.

• At least one (1) year of experience in a cleanroom, central sterile services department, sterile processing, or medical device or pharmaceutical manufacturing; fresh graduates will be considered.
  KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of ISO 14644, ISO 11607, sterilization standards (ISO 17665, ISO 11135) and ISO 13485 record keeping.

• Aseptic technique and contamination control.

• Meticulous and disciplined in documentation.

• Ability to read technical standards and equipment manuals in English.

• Alignment with VinUni’s core values (EXCEL): Empathy, Exceptional Capability, Creativity, Entrepreneurial Spirit, and Leadership Mindset
  COMPENSATION & BENEFITS
  The salary and benefits are competitive and commensurate with qualifications and experience.
  We thank all applicants for their interest. Please note that only those candidates selected for interviews will be contacted.