PR/118363 | Validation Engineer

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