Job Information
Amgen Sr Validation Engineer in Dún Laoghaire, Ireland
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