Requires Masters or foreign degree equivalent in Computer Science, Project Management or related field plus 2 years of related experience. Requires 1 year of experience with regulatory requirements for computer software, including reviewing, modifying, and documenting computer system validation CSV lifecycle, installation qualification IQs, operational qualification OQs, performance and process qualification PQs, and FDA validation; FDA Med Dev or Pharma CAPA; writing test scripts and analyzing QC of validation activities; and project management for prioritizing validation activities and workload.

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