Validation Engineer (Quality Engineering )

Kaifa Technology; Kulai; On-site; MYR 60,000 - 90,000; Full time

Job summary

Kaifa Technology in Malaysia seeks a seasoned Validation Engineer to plan and execute validation activities across equipment, processes, systems, software, and products. You will prepare protocols and reports, maintain CAPA records, and ensure compliance with GDP and ISO 13485 standards.

The role involves risk assessment, deviation handling, investigation of quality issues, and collaboration with cross-functional teams to drive continual improvement and robust quality systems.

Qualifications

• 2–3 years of experience in validation, quality assurance, quality engineering, or CAPA management.
• Bachelor’s degree in Engineering, Science, Quality Management, or equivalent.
• Experience planning, executing, documenting, and reviewing validation activities.
• Knowledge of GDP, CAPA processes, root cause analysis tools, risk management, and CI.

Responsibilities

• Plan and perform validation activities for equipment, processes, systems, software, and products.
• Prepare, review, and maintain validation protocols, reports, CAPA records, and related quality documents.
• Support validation activities, including risk assessment, testing, deviation handling, and validation closure.
• Investigate quality issues such as nonconformances, deviations, customer complaints, and audit findings.
• Coordinate with Project and others SME for Change Management Process.
• Conduct root cause analysis using appropriate problem-solving tools.
• Develop, implement, and monitor corrective and preventive actions (CAPA).
• Verify and document the effectiveness of CAPA actions.
• Ensure validation and CAPA activities comply with quality management system requirements and applicable standards.
• Maintain accurate records and proper document control for validation and CAPA activities.
• Collaborate with cross-functional teams to support quality improvement initiatives.

Skills

Analytical skills

Problem solving

Communication

Documentation

Education

Bachelor's degree in Engineering, Science, Quality Management

Job description

• Plan and perform validation activities for equipment, processes, systems, software, and products.
• Prepare, review, and maintain validation protocols, reports, CAPA records, and related quality documents.
• Support validation activities, including risk assessment, testing, deviation handling, and validation closure.
• Investigate quality issues such as nonconformances, deviations, customer complaints, and audit findings.
• Coordinate with Project and others SME for Change Management Process
• Conduct root cause analysis using appropriate problem-solving tools.
• Develop, implement, and monitor corrective and preventive actions (CAPA).
• Verify and document the effectiveness of CAPA actions.
• Ensure validation and CAPA activities comply with quality management system requirements and applicable standards.
• Maintain accurate records and proper document control for validation and CAPA activities.
• Collaborate with cross-functional teams to support quality improvement initiatives.

Requirement :

• Minimum 2–3 years of relevant experience in validation, quality assurance, quality engineering, CAPA management, manufacturing engineering, or a related technical field.
• Bachelor’s degree in Engineering, Science, Quality Management, or an equivalent technical discipline.
• Experience in planning, executing, documenting, and reviewing validation activities for equipment, processes, systems, software, or products.
• Experience in investigating non conformances, deviations, customer complaints, audit findings, quality issues and change management.
• Knowledge of validation principles, CAPA processes, root cause analysis tools, risk management, and continuous improvement methodologies.
• Familiarity with quality management systems and applicable regulatory or industry standards is preferred.
• Knowledge of

Good Documentation Practices (GDP) and data integrity principles.

• Strong analytical, problem-solving, communication, and documentation skills.
• Familiarity with quality management systems ISO 13485 and applicable regulatory or industry standards is preferred.