Manufacturing Systems Validation Engineer I

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

Job summary

Amgen is seeking an Associate MFG Systems Engineer I to lead development and implementation of the site Validation Master Plan at the ANC facility. You will generate validation plans and qualification reports, drive failure analyses, and ensure successful completion of autoclave and cleaning validation milestones.

The role requires strong technical writing, project management, and collaboration across Manufacturing, Engineering, Quality, and Process Development.

Qualifications

• Bachelor’s degree or higher in a scientific or engineering field.
• Experience in manufacturing/operations and validated environments.
• Strong technical writing and presentation skills.

Responsibilities

• Provide support for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities.
• Collaborate with project leads for validation outcomes related to equipment commissioning and qualification.
• Develop and review validation documentation (e.g., VMP, validation plans, qualification reports).
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to meet validation requirements.

Skills

Technical writing

Project management

Reading P&IDs

Collaboration

Education

Bachelor's degree

Associate’s degree

High school diploma / GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi

Job description

Amgen is seeking an Associate MFG Systems Engineer I to lead development and implementation of the site Validation Master Plan at the ANC facility. You will generate validation plans and qualification reports, drive failure analyses, and ensure successful completion of autoclave and cleaning validation milestones.

The role requires strong technical writing, project management, and collaboration across Manufacturing, Engineering, Quality, and Process Development.