Senior Validation Engineer
4 weeks ago
Our client, a medical technology company specializing in artificial heart valves and hemodynamic monitoring is hiring a Validation Engineer to join their team in Irvine, CA. (Onsite)
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.
Local Candidates Only - W2 Only
Deadline by Mid - Next Week.
Might you know of someone who would be interested?
Duration: 12 Months Contract - w/potential extension.
Location: 100% Onsite in Irvine CA 92614
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 the 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 workers 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 drawings, schematics, and computer-generated reports.
Education/Experience:
- Bachelor's degree in engineering required.
- 3-5 years’ experience required.
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