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Validation Engineer

4 months ago


Irvine, United States Compunnel Full time

Job Description: The main function of a validation engineer is to apply quality and regulatory standards to equipment and process qualification. A typical validation engineer has the ability to perform statistical analysis, monitor process qualification activities, perform root-cause analysis for any protocol deviations or failures, and compile process qualification reports.

Job Responsibilities:

Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards as well as ensure accuracy of process qualification specifications.

Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance and protocol specifications.

Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.

Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.

Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.

Evaluate data and write reports to validate or indicate deviations from existing standards.

Skills:

Creativity, verbal and written communication skills, analytical and problem solving ability.

Team player and detail oriented.

Ability to perform statistical analysis and draw meaningful conclusions.

Packaging and Sterile barrier validation experience is a plus

Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.

Education/Experience:

Bachelor's degree in engineering required.

3-5 years experience required.