Validation Engineer | Biotech GMP Manufacturing

BioSpace; West Greenwich (RI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Stock-based incentives

Job summary

Amgen Rhode Island is seeking a Validation Engineer to support validation activities for manufacturing equipment, facilities, and utilities. The role sits in the Product Lifecycle Management organization and focuses on new product introductions, PRI, and lifecycle management across ARI facilities.

The ideal candidate has GMP pharma/biotech experience, strong analytical and writing skills, and the ability to work across manufacturing, engineering, automation, and quality functions.

Qualifications

• Experience in GMP pharma/biotech environment preferred.
• Ability to interpret engineering documentation for validation testing.
• Strong writing skills for compliant documentation.

Responsibilities

• Support strategy and execution of validation activities for equipment and systems.
• Coordinate qualification activities across CIP, SIP, autoclave systems, and utilities.
• Serve as validation expert during planning, reviews, and change control.
• Develop and approve validation plans and documentation.
• Investigate issues and provide solutions for validation challenges.
• Support cleaning validation and continued verification activities.
• Maintain cleaning acceptance criteria and MAC calculations.
• Drive continuous improvement and provide training on validation.

Skills

GMP experience

Analytical skills

Technical writing

Verbal communication

Project coordination

Independent work

Biotech manufacturing knowledge

Education

Master's degree

Bachelor's degree

Associates degree

High school diploma / GED

Job description

Amgen Rhode Island is seeking a Validation Engineer to support validation activities for manufacturing equipment, facilities, and utilities. The role sits in the Product Lifecycle Management organization and focuses on new product introductions, PRI, and lifecycle management across ARI facilities.

The ideal candidate has GMP pharma/biotech experience, strong analytical and writing skills, and the ability to work across manufacturing, engineering, automation, and quality functions.