Quality Validation Engineer

Sr Technical Recruiter at Mastech Digital

Responsibilities :

• MS Word, Excel, Project
• Typical daily tasks : Quality Reviews and assessment of Non?conformances, Change orders.
• Review and approve development studies.
• Attend project meetings and draft Validation protocols & reports, assist in execution.
• Preferred background / prior work experience : Validation experience in custom equipment.
• Design validation protocols and statistical sampling.
• Risk assessment in FMEA format.
• Good at problem solving.
• Working cross?functionally with other departments.
• Organized able to manage multiple projects and tasks.
• Communication keeping every department in the project aware of the project needs.

Job Summary

The Quality Engineer II is responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities / utilities qualification, and raw materials qualification. Additionally, generate and maintain process FMEA for production processes, perform risk assessments for process related non?conformances and planned deviations, provide support and content for regulatory submissions, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders.

Essential Duties and Responsibilities

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