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 CMO
• Identify and assess validation/quality risks to enable risk-based decisions
• Validation document author/approver
• Aseptic processing system oversight (media fill, autoclave validation, EM)
• Prepare materials/documents (playbooks) for topics to be presented during audits/inspections
• Perform validation change control assessments
• Review/approve validation deviations
• Review/approve Master Batch Records
• Perform Person in Plant activities as required
• Escalate issues to Validation/Quality management, as needed
• Write/review responses to regulatory questions (RTQs)
• Drive Operational Excellence and Champion Change

Authority

• Determine outcome of validation activities
• Decision to approve or reject validation documentation
• Provide input on Validation position on related topics and strategy for the site
• Decision to approve Master batch Records