Validation Engineer

Job summary

Responsible on designing and developing protocols to be fulfilled so that the products under manufactured meet policies, procedures, regulatory requirements. Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements of company, industry, countries’ legislations manufacturing standards.

1. Validation Evaluation for new or modified process/equipment system/facility

   • Process characterization study
   • Identify key process variables that would affect product quality
   • Identify equipment critical part/feature that would affect process parameter and product quality
   • Hazard Analysis/risk assessment and other process study
   • Develop VMP for whole processes of production by product with necessary justifications based on above assessment/study

2. Design and develop validation protocol

   • Design validation study features, such as sampling, testing, or analytical methodologies.
   • Direct validation activities, such as protocol creation or testing.
   • Prepare validation protocols for new or modified manufacturing processes, systems, or equipment.
   • Study product characteristics or customer requirements to determine validation objectives and standards.

3. Conduct validation or qualification tests based on internal protocols and/or external standards.

   • Assist in training operators or other staff on validation protocols.
   • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
   • Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
   • Identify deviations from established product or process standards and provide recommendations for resolving deviations.
   • Manage deviations and changes in order to guarantee that these are well documented and corrective actions are taken and followed up upon.
   • Draw samples of raw materials, or intermediate and finished products for validation testing.
   • Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
   • Procure or devise automated validation test stations or other test fixtures and equipment.
   • Align facility validation strategies and policies with actual outcomes

4. Continuous competence development in Validation and maintenance of validation documentation and database

   • Communicate with regulatory agencies regarding compliance documentation or validation results.
   • Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or technologies.
   • Prepare, maintain, or review validation and compliance documentation.
   • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.

Qualification

• Bachelor's degree in engineering or science.
• Above 4 years relative work experience in QC/QA or similar in the medical device industry
• Excellent problem resolution, judgment, and decision-making skills required with thorough working knowledge of QC tools, methods and practices.
• Experience/familiarity with regulated product quality system requirements, i.e. ISO 13485, FDA Quality System Regulations, ISO 14971, and other applicable standards.
• Good command of English in communication
• Good command of MS office software application

Working Conditions

• Working Days: Monday to Friday
• Working Hours: 08:30 – 17:30
• Uniform: Not required
• Company Transportation: Not provided
• Canteen: Available (note: no food vendor on-site)

Benefits

• Fixed Bonus
• Variable Bonus
• Group Insurance
• Provident Fund