Validation Engineer I: Manufacturing Validation Lead

Amgen; Holly Springs (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Annual bonus program

Flexible work models

Job summary

Amgen is seeking a Validation Engineer I in North Carolina to lead development and execution of validation strategies for manufacturing processes and equipment at the ANC facility. You will generate and review critical documents such as Master Plans, validation plans, and qualification reports while ensuring alignment with GMP requirements.

The role involves cross-functional collaboration with Manufacturing, Engineering, Quality, and Process Development, supporting regulatory submissions and

Qualifications

• Bachelor’s degree or higher in a related field plus manufacturing/operations exposure.

Responsibilities

• Provide technical lead support for commissioning, qualification, cleaning validation and validation maintenance.
• Coordinate with Manufacturing, Engineering, Quality, and Process Development to meet validation requirements.
• Develop and review validation documents (Master Plan, plans, protocols, reports).
• Support regulatory filings, audits, and inspections with validation input.
• Create/update cleaning process SOPs and work instructions.

Skills

Technical writing

Verbal communication

Project management

Validation strategies

Cross-functional collaboration

Education

Bachelor’s degree in a related field

Master’s degree

Associate’s degree

High school diploma / GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi

Job description

Amgen is seeking a Validation Engineer I in North Carolina to lead development and execution of validation strategies for manufacturing processes and equipment at the ANC facility. You will generate and review critical documents such as Master Plans, validation plans, and qualification reports while ensuring alignment with GMP requirements.

The role involves cross-functional collaboration with Manufacturing, Engineering, Quality, and Process Development, supporting regulatory submissions and