Validation Engineer I - Equipment Qualification Lead

Amgen SA; Holly Springs (NC); On-site; USD 95,000 - 120,000; Full time

Job summary

Amgen North Carolina manufacturing facility seeks a Validation Engineer I to lead the development and implementation of the Validation strategy, master plans, and qualification protocols for autoclave and cleaning validation and related activities. The role collaborates with Manufacturing, Engineering, Quality and Process Development to ensure GMP alignment and successful qualification outcomes.

You will provide technical support for commissioning, qualification, and validation maintenance,

Qualifications

• Proficient technical writing and presentations skills to collaborate with technical and senior management staff.
• Strong written and verbal skills with the ability to work with minimal direction.
• Experience in equipment qualification and cleaning validation for biologics facilities.
• Project management experience and ability to manage multiple priorities.
• Experience reviewing validation protocols and reports for commissioning and qualification.
• Familiarity with validation tasks for cleaning validation, steaming validation, and CTC.
• Knowledge of FDA regulations, Eudralex Annex 15, and ICH Q7.

Responsibilities

• Lead development and implementation of the site validation strategy and related documents.
• Generate and review Validation Master Plans, qualification protocols/reports.
• Coordinate with Manufacturing, Engineering, Quality, and Supply Chain to meet validation requirements.
• Provide technical support for commissioning, qualification, cleaning/sterilization validation.
• Support regulatory filings, audits, and inspections related to validation.
• Maintain site validation Master Plan and monitor status/compliance.
• Contribute to continuous improvement initiatives and troubleshooting to reduce downtime.

Skills

Technical writing

Presentations

Project management

Cross-functional collaboration

Regulatory compliance

Root cause analysis

Troubleshooting

Education

Bachelor’s degree in a relevant field

Master’s degree

Associate’s degree

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi

Job description

Amgen North Carolina manufacturing facility seeks a Validation Engineer I to lead the development and implementation of the Validation strategy, master plans, and qualification protocols for autoclave and cleaning validation and related activities. The role collaborates with Manufacturing, Engineering, Quality and Process Development to ensure GMP alignment and successful qualification outcomes.

You will provide technical support for commissioning, qualification, and validation maintenance,