Validation Engineer | GMP Biotech Manufacturing

Amgen Inc. (IR); West Greenwich, Northern (RI, KY); Hybrid; USD 86,000 - 116,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Flexible work models where possible

Job summary

Amgen Rhode Island is seeking a Validation Engineer to support validation strategy and execution for manufacturing equipment, utilities, and related systems. You will coordinate qualification activities and contribute to lifecycle documentation in a fast-paced, GMP biotech environment.

The role emphasizes technical writing, cross-functional collaboration, and applying science-based approaches. Monday–Friday schedule with potential training opportunities and career development within Amgen.

Qualifications

• High school diploma or GED with 8 years in manufacturing/operations.
• Associate’s degree with 6 years in manufacturing/operations.
• Bachelor’s degree with 2 years in manufacturing/operations.
• Master’s degree is acceptable for consideration.

Responsibilities

• Support validation strategy and execute validation activities for manufacturing equipment, support equipment, and utilities.
• Plan and coordinate qualification activities across CIP, SIP, autoclave systems, and related utilities.
• Interpret engineering docs to determine validation requirements and testing approaches.
• Develop and review validation plans and documentation for changes and equipment modifications.

Skills

GMP knowledge

Validation testing

Analytical skills

Technical writing

Cross-functional collaboration

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

Job description

Amgen Rhode Island is seeking a Validation Engineer to support validation strategy and execution for manufacturing equipment, utilities, and related systems. You will coordinate qualification activities and contribute to lifecycle documentation in a fast-paced, GMP biotech environment.

The role emphasizes technical writing, cross-functional collaboration, and applying science-based approaches. Monday–Friday schedule with potential training opportunities and career development within Amgen.