Job summary:
Responsible on designing and developing protocols to be fulfilled so that the products under manufactured meet policies, procedures, regulatory requirements. Sr. Validation Engineer Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements of company, industry, countries’ legislation manufacturing standards.
Responsibilities:
1. Validation Evaluation for new or modified process/equipment system/facility
a) Process characterization study;
b) Identify key process variables that would affect product quality
c) Identify equipment critical part/feature that would affect process parameter and product quality
d) Hazard Analysis/risk assessment and other process study
e) Develop VMP for whole processes of production by product with necessary justifications based on above assessment/study
2. Design and develop validation protocol
a) Design validation study features, such as sampling, testing, or analytical methodologies.
b) Direct validation activities, such as protocol creation or testing.
c) Prepare validation protocols for new or modified manufacturing processes, systems, or equipment for medical, electronics, or other types of production.
d) 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.
a) Assist in training operators or other staff on validation protocols.
b) Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
c) Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
d) Identify deviations from established product or process standards and provide recommendations for resolving deviations.
e) Manage deviations and changes in order to guarantee that these are well documented and corrective actions are taken and followed-up upon.
f) Draw samples of raw materials, or intermediate and finished products for validation testing.
g) Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
h) Procure or devise automated validation test stations or other test fixtures and equipment.
i) Align facility validation strategies and policies with actual outcomes
4. Continuous competence development in Validation and maintenance of validation documentation and database
a) Communicate with regulatory agencies regarding compliance documentation or validation results.
b) Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or technologies.
c) Prepare, maintain, or review validation and compliance documentation.
d) Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
5. Deal with other assignments assigned by superior.
Qualification:
1. Bachelor or above, major in electronics, electromechanical or equivalent.
2. Above 6 years relative work experience, QA experience is a plus.
3. Good command of reading & written English.
4. proactive, responsible, independent.