Senior Engineer-Validation, Cleaning Validation

About the role

Amgen is hiring a Senior Engineer-Validation for its North Carolina manufacturing facility, which will be part of the new FleX Batch drug substance plant combining disposable technologies with stainless steel equipment and Industry 4.0 capabilities. The role acts as technical lead and subject matter expert for the validation strategy, covering cleaning validation, autoclave performance qualification and validation maintenance.

Key responsibilities

• Lead a team implementing and maintaining the facility's cleaning validation and sterilization program
• Provide technical support for commissioning, qualification, cleaning/sterilization validation and validation maintenance
• Work with project leads on validation outputs for equipment commissioning and qualification
• Generate, review and approve cleaning documents such as characterization/inactivation and acceptance limits reports
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain and Process Development to meet validation requirements
• Represent validation for regulatory filings, audits and inspections
• Maintain the site validation master plan and monitor validation status and regulatory compliance
• Support continuous improvement initiatives

Required profile

• Doctorate, or Master's degree plus 3 years of validation or engineering experience, or Bachelor's degree plus 5 years, or Associate's degree plus 10 years, or high school diploma plus 12 years of validation or engineering experience
• Direct experience managing people and/or leading teams, projects or resource allocation
• Preferred: experience managing staff safely and in compliance, and extensive experience reviewing validation protocols and reports

Required skills

• Equipment qualification and cleaning validation, including validation strategies and procedures for biologics facilities
• Knowledge of Eudralex Annex 15, FDA 21 CFR Parts 210 and 211, ASTM E2500 and ICH Q7
• Experience with autoclaves and controlled temperature chambers, and participation in regulatory submissions and inspections
• Technical writing and presentation skills

What we offer

• Career development resources and a diverse, inclusive community
• Total rewards plan covering health, finance, work-life balance and career benefits