Sr Validation Engineer

Description The Senior Validation Engineer will work remotely and report to the External Supply Quality Validation Pod lead, located in the US. The selected candidate will oversee strategies and documents related to process, cleaning, filter and sterilization/sanitization validation activities at contract manufacturing organizations (CMOs) located across North America and Europe. CMOs will range across synthetics, small molecules and large molecule products at API, DS, DP and FDP manufacturing sites.
Key Responsibilities Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will include: tech transfers, new product introductions, and ongoing validation maintenance activities.Translate Amgen requirements into the language of the CMOIdentify and assess validation/quality risks to enable risk-based decisionsValidation document author/approverAseptic processing system oversight (media fill, autoclave validation, EM)Prepare materials/documents (playbooks) for topics to be presented during audits/inspectionsPerform validation change control assessmentsReview/approve validation deviationsReview/approve Master Batch RecordsPerform Person in Plant activities as requiredEscalate issues to Validation/Quality management, as neededWrite/review responses to regulatory questions (RTQs)Drive Operational Excellence and Champion ChangeAuthority Determine outcome of validation activitiesDecision to approve or reject validation documentationProvide input on Validation position on related topics and strategy for the siteDecision to approve Master batch Records
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