Validation Engineer

1 week ago

Ho Chi Minh City Metropolitan Area, Vietnam HR Agent Full time


• Develop and execute validation protocols (Installation Qualification, Operational Qualification, Performance Qualification – IQ/OQ/PQ).


• Conduct risk assessments and define validation acceptance criteria.


• Perform validation for equipment, facilities, utilities (e.g., HVAC, purified water systems), and manufacturing processes and computer system validation activities.


• Prepare and maintain validation documentation, including plans, protocols, reports, and traceability matrices, in accordance with cGMP standards.


• Review and approve validation documentation from vendors and contractors.


• Ensure validation activities are aligned with current regulatory guidelines (FDA, EMA, ICH, WHO, ISO…).


• Participate in change control, deviation, and CAPA management related to validation.


•
Bachelor's or Master's degree in engineering (Chemical, or Biomedical), Life Sciences, or a related field.


•
English - Business Level.


• Experience: Minimum 5 years of experience in a GMP-regulated environment (pharmaceuticals, biotechnology, medical devices, or similar).


•
Strong understanding of validation principles, quality systems, and regulatory requirements (21 CFR Parts 210/211, Part 11, EU GMP Annex 15, ICH Q7–Q10, GAMP

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