125109 - Validation Engineer - Engineering Services

Position Name:
Validation Engineer- Engineering Services
Job code:
125109
- Work Location:
Tan My Ward, HCMC.
- Monthly Salary:
Negotiable
• 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.
• Participate in change control, deviation, and CAPA management related to validation.
• Develop and execute validation protocols (Installation Qualification, Operational Qualification, Performance Qualification – IQ/OQ/PQ).
• Perform validation for equipment, facilities, utilities (e.g., HVAC, purified water systems), and manufacturing processes and computer system validation activities.
• Conduct risk assessments and define validation acceptance criteria.
• Ensure validation activities are aligned with current regulatory guidelines (FDA, EMA, ICH, WHO, ISO…).

・Experience: Minimum 5 years of experience in a GMP- regulated environment (pharmaceuticals, biotechnology, medical devices, or similar).
・Excellent documentation, communication, and project management skills.
・Education: Bachelor’s or Master’s degree in engineering (Chemical, or Biomedical), Life Sciences, or a related field.
・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 5).
・Strong attention to detail and ability to manage multiple projects simultaneously.
・Language: English- Business Level.
・Experience with equipment, utility, process, and computerized systems validation (CSV).
・Knowledge of statistical tools and risk- based validation approaches (e.g., FMEA).

・Collaborative team player with cross- functional experience.
・Proactive and adaptable in fast- paced environments.
・Analytical and problem- solving mindset.
・Strong written and verbal communication skills.
・High level of integrity and commitment to quality.

NOTICE:

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Cập nhật gần nhất lúc: 2025-11-18 23:35:02