Validation Engineer I: Quality & Validation Lead

Amgen; Holly Springs (AL); On-site; USD 86,000 - 116,000; Full time

Job summary

Amgen is seeking a Validation Engineer I to lead development and execution of validation strategies at Amgen facilities in the U.S. The role focuses on cleaning validation, equipment qualification, and validation maintenance with a strong emphasis on regulatory compliance and quality systems.

Ideal candidates will have strong technical writing skills, cross-functional project management experience, and the ability to work in a collaborative team environment across manufacturing, process

Qualifications

• High school diploma or equivalent with 8 years manufacturing/operations experience, or
• Bachelor’s degree with 2+ years manufacturing/operations experience, or

Responsibilities

• Provide technical support for commissioning, qualification, cleaning validation, and maintenance activities.
• Coordinate validation deliverables with cross-functional teams including Manufacturing, Engineering, Quality, and Process Development.
• Develop and review validation documentation (Master Plan, plans, SOPs) and support regulatory filings.

Skills

Technical writing

Verbal communication

Project management

Interpersonal skills

Team collaboration

Education

High school diploma / GED (8 years exp)

Associate’s degree (6 years exp)

Bachelor’s degree (2 years exp)

Master’s degree

Tools

Kneat

CDOCs

Laboratory Inventory Management System

PI (Process Intelligence)

Job description

Amgen is seeking a Validation Engineer I to lead development and execution of validation strategies at Amgen facilities in the U.S. The role focuses on cleaning validation, equipment qualification, and validation maintenance with a strong emphasis on regulatory compliance and quality systems.

Ideal candidates will have strong technical writing skills, cross-functional project management experience, and the ability to work in a collaborative team environment across manufacturing, process