As a key member of our client's Validation team, you will be essential in designing and planning test criteria to ensure products meet quality standards.
Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
Direct validation activities, such as protocol creation or testing.
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
Draw samples of raw materials, intermediate products, or finished products for validation testing.
Resolve testing problems by modifying testing methods or revising test objectives and standards.
Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
Design validation study features, such as sampling, testing, or analytical methodologies.
Recommend resolution of identified deviations from established product or process standards.
Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
Maintain validation test equipment.
Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
Study product characteristics or customer requirements to determine validation objectives and standards.
Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
Analyzing needs and product requirements to create a design.
Conducting tests and inspections of products, services, or processes to evaluate quality or performance.
Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
Six Sigma Green or Black Belt certified
ASQ (American Society of Quality) certifications, such as CRE (Certified Reliability Engineer)
Spend Time Using Your Hands to Handle, Control, or Feel Objects, Tools, or Controls