Biotech Validation Engineer – GMP Equipment & Systems

BioSpace; West Greenwich (RI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive benefits

Flexible work model

Employee growth opportunities

Job summary

Amgen Rhode Island is seeking a Validation Engineer to support the Product Lifecycle Management organization. The role focuses on validation planning, qualification of equipment and utilities, and lifecycle documentation for manufacturing processes.

The position is Monday–Friday, with an admin day shift, at the Rhode Island manufacturing facility. You will collaborate across manufacturing, engineering, automation, and quality functions, applying risk-based approaches and CFR guidance to ensure

Qualifications

• Experience in GMP pharmaceutical/biotech manufacturing preferred.
• Hands-on validation experience with equipment, sterilization/steam, cleaning validation, and testing.
• Ability to interpret engineering and automation docs to derive validation tests.
• Strong understanding of GMP CFR/regulatory expectations and applying them to validation activities.

Responsibilities

• Support validation strategy and execute activities for manufacturing equipment, support equipment, and utilities.
• Plan and coordinate qualification activities across CIP, SIP, autoclaves, and related systems.
• Serve as validation expert during planning, design reviews, and change control; develop validation plans.
• Generate, review, and approve validation documentation and assess changes and equipment modifications.
• Investigate technical issues and develop solutions for validation challenges of moderate complexity.
• Maintain cleaning validation and continued verification activities; manage MAC calculations and justify criteria.

Skills

Analytical thinking

Experimental design

Technical writing

Verbal communication

Project coordination

Independent work

Education

High school diploma / GED

Associate degree

Bachelor’s degree

Master’s degree

Job description

Amgen Rhode Island is seeking a Validation Engineer to support the Product Lifecycle Management organization. The role focuses on validation planning, qualification of equipment and utilities, and lifecycle documentation for manufacturing processes.

The position is Monday–Friday, with an admin day shift, at the Rhode Island manufacturing facility. You will collaborate across manufacturing, engineering, automation, and quality functions, applying risk-based approaches and CFR guidance to ensure