The engineer will provide Validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities.
- Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
- Translates Amgen requirements into the language of the CMO-can make a risk-based decision
- Validation document author/approver
- Ensure validated parameters are correctly incorporated in Master Batch Records
- Regulatory - Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship
- Validation change control assessment
- Perform Person in Plant activities as required
- Author applicable MA filing sections
- Write/review RTQs
- Prepare inspection playbooks
- Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
- Drive Operational Excellence and Champion Change
- Determine validation strategy and outcome of validation activities
- Decision to approve or reject validation documentation
- Provide Validation position on related topics and strategy for the site
- Degree qualified in science and/or engineering
- 5 + years (ideally 8 years +) biotech or pharmaceutical industry experience
- Significant Validation experience at Aseptic Manufacturing or API facilities
- Able to facilitate and influence senior stakeholders and partners
- Able to successfully manage workload and timelines
- Familiarity with basic project management tools
- Ability to negotiate a strategic position after taking feedback from multiple sources (dealing with CMOs, communicate with others where English isn't first language)
- Strong project management, problem-solving, and analytical skills
- Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership
- Experience driving decision making
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.