Associate Manufacturing Systems Engineer I — Validation Lead

Amgen; Holly Springs (MS); On-site; USD 87,000 - 117,000; Full time

Benefits offered by this job

Job summary

Amgen is seeking an Associate MFG Systems Engineer I to lead validation strategy development and execution at the ANC manufacturing facility. You will generate and review validation Master Plans, qualification protocols, and reports while driving autoclave and cleaning validation milestones.

You will collaborate with Manufacturing, Engineering, Quality, Supply Chain and Process Development to ensure comprehensive validation coverage and continuous improvement across the site.

Qualifications

• Technical writing and presentations skills to collaborate with technical and senior management staff.
• Familiarity with validation concepts and documentation in a biotech manufacturing setting.
• Ability to read P&IDs and understand process flow and equipment interfaces.

Responsibilities

• Develop and implement the Validation Master Plan and related protocols at the ANC site.
• Lead qualification of equipment and cleaning validation activities for manufacturing processes.
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain and Process Development to meet validation requirements.

Education

High school diploma or GED

Associate’s degree

Bachelor’s degree

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi

Job description

Amgen is seeking an Associate MFG Systems Engineer I to lead validation strategy development and execution at the ANC manufacturing facility. You will generate and review validation Master Plans, qualification protocols, and reports while driving autoclave and cleaning validation milestones.

You will collaborate with Manufacturing, Engineering, Quality, Supply Chain and Process Development to ensure comprehensive validation coverage and continuous improvement across the site.