Validation Engineer
Tranzeal, Inc.
Marana, AZ (In Person)
Full-Time
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Job Description
< class=contents> Validation Engineer Seeking a Validation Engineer with 1-3 years of experience in FDA-regulated medical device, pharmaceutical, or biotech manufacturing environments. Responsibilities Write, review, and execute validation protocols and reports Support IQ, OQ, PQ, process validation, and process verification activities Perform risk assessments and CPK analysis Analyze validation data and ensure cGMP/FDA compliance Partner with Manufacturing, Quality, and Operations teams on process improvements and corrective actions Maintain validation documentation and audit readiness Support reagent manufacturing processes and related floor activities Qualifications Bachelor s degree in Mechanical/Chemical Engineering or Life Sciences 1-3 years of validation experience in regulated manufacturing Strong understanding of IQ/OQ/PQ, cGMP, and validation principles Strong technical writing, analytical, and problem-solving skills Comfortable working between manufacturing floor and documentation tasks
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