Biotech Cleaning Validation Manager

Amgen SA; Holly Springs, Northern (NC, KY); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Career development resources

Total rewards plan

Job summary

Amgen North Carolina (ANC) is seeking a Manufacturing Manager Programs – Cleaning Validation to serve as a technical lead for validation strategy at the new FleX Batch facility. The role focuses on developing and implementing the Validation Master Plan, qualification protocols, and regulatory-ready documentation for autoclave and cleaning validation.

You will manage a team, collaborate across functions, and drive continuous improvement while ensuring compliance with FDA and global guidelines.

Qualifications

• Requires advanced degree with leadership/people-management experience.
• Experience in validation, engineering, or manufacturing environments.
• Strong technical writing and collaboration skills.

Responsibilities

• Lead team for cleaning validation and sterilization programs.
• Provide technical support for commissioning, qualification, cleaning/sterilization validation, and maintenance.
• Coordinate with Manufacturing, Engineering, Quality, and Supply Chain to meet validation requirements.
• Support regulatory filings, audits, and inspections; maintain validation Master Plan.

Skills

Leadership experience

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Job description

Amgen North Carolina (ANC) is seeking a Manufacturing Manager Programs – Cleaning Validation to serve as a technical lead for validation strategy at the new FleX Batch facility. The role focuses on developing and implementing the Validation Master Plan, qualification protocols, and regulatory-ready documentation for autoclave and cleaning validation.

You will manage a team, collaborate across functions, and drive continuous improvement while ensuring compliance with FDA and global guidelines.