Validation Engineer – Biotech Manufacturing & GMP

Amgen SA

West Greenwich (RI)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Job summary

Amgen Rhode Island is seeking a Validation Engineer to support the validation strategy for manufacturing equipment, support systems, and utilities. The role is within the Product Lifecycle Management organization at ARI, with a focus on NPI/PRI and lifecycle management of ARI’s portfolio.

You will coordinate qualification activities across CIP/SIP and autoclave systems, apply risk-based approaches, and contribute to continuous improvement of validation programs. Monday–Friday admin day shift.

Qualifications

Experience in GMP pharmaceutical/biotechnology manufacturing.
Hands-on validation experience with equipment, facilities, and utilities.
Ability to interpret engineering and automation documentation for validation testing.
Strong understanding of GMP requirements and CFR/regulatory expectations.
Strong technical writing and communication 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.
Act as validation expert during planning, reviews, and change control; develop validation plans.
Generate, review, and approve validation documentation and assess validation impact of changes.
Investigate technical issues and support cleaning validation and verification activities.