Specialist Manufacturing - Cleaning Validation
Amgen Inc
Amgen seeks a manufacturing specialist to lead cleaning validation and equipment cleanability assessments for drug substance production at its Thousand Oaks facility. The role involves managing cross-functional projects, developing validation strategies, supporting operations, and maintaining compliance with regulatory requirements.
Responsibilities
- Own cleaning and sterilization validation requirements for new product introductions and existing products, including MAC/MAR assessments
- Lead cross-functional projects from planning through implementation across manufacturing, quality, engineering, and supply chain
- Provide technical support to manufacturing operations including troubleshooting, deviation investigation, and corrective action implementation
- Develop and review cleaning validation protocols, reports, acceptance limits, and sampling plans
- Maintain site validation status, conduct routine monitoring, analyze trends, and represent cleaning validation during regulatory audits
Requirements
- Doctorate degree, or Master's with 2 years relevant experience, or Bachelor's with 4 years experience, or Associate's with 8 years experience
- Background in validation, engineering, GMP manufacturing, or process development
- Expertise in equipment cleanability, cleaning/sterilization validation, and MAC/MAR calculations in biologics
- Demonstrated ability to lead complex cross-functional projects and manage competing priorities
- Strong technical writing and data analysis skills for regulatory and leadership communication
- Experience developing validation strategies, protocols, and acceptance limits
Vacancy posted 5 days ago
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