Senior Validation Engineer

• 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.
• Translate Amgen requirements into the language of the CMO
• Identify and assess validation/quality risks to enable risk-based decisions
• Validation document author/approver
• Oversight of packaging process qualification, device and combination product qualifications
• Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes
• Implement statistical methods to create risk based sampling plans and acceptance criteria
• Oversight of synthetic API manufacturing process validation and cleaning validation
• 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
• Author Validation sections of Marketing Applications
• Write/review responses to regulatory questions (RTQs)
• Drive Operational Excellence and Champion Change

• Doctorate degree OR Master’s degree with 4 to 6 years of experience in process validation or a related field OR Bachelor’s degree with 6 to 8 years of experience in process validation or a related field OR Diploma with 10 to 12 years of experience in process validation or a related field
• Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes
• Relevant experience in qualification of finished drug product and packaging processes
• Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations
• Ability to have a positive impact on others
• the ability to affect the behaviors of others by connecting with and inspiring them
• Direct experience with qualification/validation of primary and secondary packaging processes, including device / combination products is required
• Experience with validation of synthetic API manufacturing processes is also highly desired
• Prior experience with, or willingness to learn, other modalities, including biologic drug substance and aseptic drug product is also desired
• The candidate should be able to travel within the JAPAC region, specifically Japan

• Working foundation in cleaning validation and aseptic process simulation
• Experience in resolving complex deviations associated with validation studies
• Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Proven experience in designing and/or improving processes at conceptual level
• Desire to partner with internal and external stakeholders across teams
• Understanding of industry requirements/expectations that comprise a robust Validation package

Reasonable accommodation for individuals with disabilities