Description
Amgen is hiring a Senior Validation Engineer to provide quality oversight and technical leadership for analytical method validation, transfer, verification, and ongoing performance monitoring at external contract manufacturing organizations. The role also oversees cleaning and process validation programs for synthetic API and peptide manufacturing, including protocol and report review, data integrity assessments, investigations, CAPAs, and compliance guidance. Candidates need strong analytical validation expertise, GMP and data integrity knowledge, and at least six years of cGMP manufacturing experience; experience with synthetic API and peptide manufacturing is desirable, along with the ability to work across global time zones and travel to CMO sites.
