Associate Mfg Systems Engineer I - Validation Lead (Hybrid)

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

Job summary

Amgen in North Carolina is seeking an Associate Manufacturing Systems Engineer I to drive validation strategy and documentation at the ANC manufacturing facility. You will develop and implement the Validation Master Plan, qualification protocols, and reports, supporting commissioning and qualification of process equipment.

The role requires collaboration with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure all validation requirements are met and maintained.

Qualifications

• Experience in validation/qualification activities within manufacturing or operations.
• Proven ability to read P&IDs and collaborate with cross-functional teams.

Responsibilities

• Lead development and implementation of the Validation strategy at the ANC facility.
• Develop and generate Validation Master Plan, validation plans, and qualification reports.
• Support commissioning, qualification, cleaning/sterilization validation, and maintenance activities.
• Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development.
• Contribute to continuous improvement initiatives driven by site validation.

Skills

Sample Management lifecycle

Education

Bachelor's degree

Associate’s degree

High school diploma / GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi

Job description

Amgen in North Carolina is seeking an Associate Manufacturing Systems Engineer I to drive validation strategy and documentation at the ANC manufacturing facility. You will develop and implement the Validation Master Plan, qualification protocols, and reports, supporting commissioning and qualification of process equipment.

The role requires collaboration with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure all validation requirements are met and maintained.