Biotech Validation Engineer: Impact & Compliance Leader

Biopharma Careers; West Greenwich (RI); On-site; USD 86,000 - 116,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models where possible

Job summary

Amgen Rhode Island is seeking a Validation Engineer to join the Product Lifecycle Management team at ARI, a large-scale mammalian cell biotech manufacturing site. You will lead validation activities for equipment, utilities, and cleanings, ensuring quality and regulatory compliance.

You will collaborate across manufacturing, engineering, automation, and quality functions, develop validation plans, perform testing, and drive improvements while upholding GMP and CFR standards.

Qualifications

• Bachelor’s degree or higher with experience in GMP pharma/biotech manufacturing.
• Hands-on validation exposure for equipment, facilities and utilities.
• Strong understanding of CFR/regulatory expectations and GMP requirements.
• Excellent technical writing and cross-functional collaboration skills.

Responsibilities

• Support validation strategy and execute validation activities for manufacturing equipment, support equipment, and utilities.
• Coordinate qualification activities across CIP, SIP, autoclave systems, and related studies.
• Develop and maintain Validation plans, review documentation, and assess impact of changes.
• Lead investigations and propose solutions for validation challenges of moderate complexity.
• Support cleaning validation and continued cleaning verification activities.
• Contribute to ongoing improvements of validation programs and training of staff.

Skills

Analytical skills

Verbal communication

Project coordination

Technical writing

GMP knowledge

Independent work

Education

Bachelor’s degree in relevant field

Master’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen Rhode Island is seeking a Validation Engineer to join the Product Lifecycle Management team at ARI, a large-scale mammalian cell biotech manufacturing site. You will lead validation activities for equipment, utilities, and cleanings, ensuring quality and regulatory compliance.

You will collaborate across manufacturing, engineering, automation, and quality functions, develop validation plans, perform testing, and drive improvements while upholding GMP and CFR standards.