Manufacturing Manager Programs - Cleaning Validation
Amgen Inc
Amgen seeks a Senior Engineer-Validation to lead cleaning validation and sterilization programs at its North Carolina manufacturing facility. The role involves developing validation strategies, managing teams, and ensuring regulatory compliance for a state-of-the-art drug substance manufacturing plant.
Responsibilities
- Lead team implementing and maintaining facility cleaning validation and sterilization programs
- Develop and generate validation master plan, qualification protocols, and related documentation
- Provide technical expertise and support for equipment commissioning, qualification, and validation activities
- Generate, review, and approve cleaning validation documents including characterization and acceptance limits reports
- Coordinate across Manufacturing, Engineering, Quality, and Process Development to meet validation requirements
Requirements
- Doctorate degree OR Master's degree with 3+ years validation/engineering experience OR Bachelor's degree with 5+ years experience OR equivalent
- Direct people management experience and/or team leadership experience
- Expertise in equipment qualification and cleaning validation for biologics facilities
- Knowledge of FDA Title 21 CFR Part 210/211, Eudralex Annex 15, ASTM E2500, and ICH Q7
- Technical writing and presentation skills for cross-functional collaboration
- Experience with autoclave steaming validation and controlled temperature chambers
Vacancy posted 19 days ago
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