Manufacturing Validation Engineer I

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 87,000 - 117,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical/Dental/Vision

Stock-based incentives

Time-off programs

Flexible work models

Job summary

Amgen Inc. North Carolina is seeking an Associate Manufacturing Systems Engineer I to lead the development and implementation of the Validation strategy at the ANC manufacturing facility.

You will generate key documents like the Validation Master Plan and qualification reports, while supporting commissioning, cleaning/sterilization validation, and validation maintenance. Qualifications include a high school diploma with manufacturing experience or a bachelor’s degree; preferred are technical

Qualifications

• Technical writing and presentations skills to collaborate with technical and senior management staff.
• Ability to gain expertise in equipment qualification & cleaning validation for biologics facility.
• Experience reviewing/approving validation protocols and reports in support of commissioning and qualification.

Responsibilities

• Develop and implement the Validation Master Plan and validation plans at ANC.
• Produce and review qualification protocols/reports and autoclave validation milestones.
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure Amgen validation requirements are met.

Skills

Technical writing

P&IDs reading

Project management

Education

Bachelor's degree

Associate degree

High school diploma/GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi Sample Management

Job description

Amgen Inc. North Carolina is seeking an Associate Manufacturing Systems Engineer I to lead the development and implementation of the Validation strategy at the ANC manufacturing facility.

You will generate key documents like the Validation Master Plan and qualification reports, while supporting commissioning, cleaning/sterilization validation, and validation maintenance. Qualifications include a high school diploma with manufacturing experience or a bachelor’s degree; preferred are technical