Job Description
<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.
Job Requirement
<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.