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Nơi làm việc: Hồ Chí Minh
Mức lương:
Ngành nghề: Sản xuất / Vận hành sản xuất
Hạn chót nộp hồ sơ:
Cấp bậc: Nhân viên
Kinh nghiệm:
Position Name: Validation Engineer - Engineering Services
Job code: 125109
- Work Location: Tan My Ward, HCMC.
- Monthly Salary: Negotiable
<Job Responsibilities>
• 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.
<Necessary Skill / Experience >
・Education: Bachelor’s or Master’s degree in engineering (Chemical, or Biomedical), Life Sciences, or a related field.
・Language: 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 5).
・Experience with equipment, utility, process, and computerized systems validation (CSV).
・Knowledge of statistical tools and risk-based validation approaches (e.g., FMEA).
・Excellent documentation, communication, and project management skills.
・Strong attention to detail and ability to manage multiple projects simultaneously.
<Key Competencies>
・Analytical and problem-solving mindset.
・Strong written and verbal communication skills.
・Collaborative team player with cross-functional experience.
・Proactive and adaptable in fast-paced environments.
・High level of integrity and commitment to quality.
NOTICE:
Only shortlisted candidates will be approached by RGF's consultant. Your resumes will be recorded in our system, and you will receive our Job Introduction Auto-email with suitable jobs in the coming time. Please check your email regularly to get our vacant job. Thanks so much!
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