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Validation Engineer
4 months ago
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.
