Validation Program Manager – Cleaning & Sterilization

Regulatory Jobs; Holly Springs (NC); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Career development resources

Diversity & inclusion

Total rewards plan

Job summary

Amgen seeks a senior validation leader for the North Carolina manufacturing site. The role leads the cleaning/sterilization validation program, develops the Validation Master Plan, and ensures readiness for regulatory filings and inspections.

You will oversee design and execution of validation strategies, coordinate with cross-functional teams, and drive continuous improvement in validation processes while maintaining compliance with FDA regulations.

Qualifications

• Doctorate degree OR Master’s degree with 3+ years of Validation/Engineering experience.
• In addition to degree requirements, must have experience directly managing people or leadership roles.
• Proficient technical writing and presentations skills to collaborate with technical and senior management.

Responsibilities

• Lead team responsible for cleaning validation and sterilization programs at ANC.
• Provide technical support for commissioning, qualification, cleaning/sterilization validation, and maintenance activities.
• Collaborate with project leads on validation outputs for equipment commissioning and qualification.
• Prepare and review cleaning-related documents (e.g., validation reports, acceptance limits).
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to meet validation requirements.

Skills

Leadership

Technical writing

Validation expertise

Project management

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Amgen seeks a senior validation leader for the North Carolina manufacturing site. The role leads the cleaning/sterilization validation program, develops the Validation Master Plan, and ensures readiness for regulatory filings and inspections.

You will oversee design and execution of validation strategies, coordinate with cross-functional teams, and drive continuous improvement in validation processes while maintaining compliance with FDA regulations.