Roles & Responsibilities: Translate Amgen requirements into the language of the CMO Identify and assess validation/quality risks to enable risk-based decisions Validation document author/approver Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes. 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 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 This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: 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. Functional Skills: Must-Have Skills: 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 Good-to-Have Skills: 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. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills.