Mfg Systems Engineer I – Validation Leader

Amgen SA; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

Discretionary annual bonus

Stock-based incentives

Job summary

Amgen North Carolina is seeking an Associate MFG Systems Engineer I to lead validation strategy, develop validation plans and master documents, and drive commissioning, qualification, and validation activities for manufacturing equipment. You will collaborate across Manufacturing, Engineering, Quality, and Process Development to ensure compliance and success.

The role emphasizes technical writing, validation expertise, and ability to manage multiple projects, with opportunities in a global

Qualifications

• Strong technical writing and presentation skills to collaborate with technical and management staff.
• Experience with validation strategies, equipment qualification, and cleaning validation.
• Ability to read P&IDs and coordinate multi-project validation efforts.
• Experience with validation tasks for cleaning, autoclaves and sterile processes.

Responsibilities

• Lead the development and implementation of the Validation Master Plan and related documents.
• Coordinate validation activities across Manufacturing, Engineering, Quality and Process Development.
• Review and approve validation protocols and reports for commissioning and qualification.
• Support continuous improvement initiatives in validation-related processes.

Skills

Technical writing

Presentations

Project management

P&IDs reading

Education

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi

Job description

Amgen North Carolina is seeking an Associate MFG Systems Engineer I to lead validation strategy, develop validation plans and master documents, and drive commissioning, qualification, and validation activities for manufacturing equipment. You will collaborate across Manufacturing, Engineering, Quality, and Process Development to ensure compliance and success.

The role emphasizes technical writing, validation expertise, and ability to manage multiple projects, with opportunities in a global