Validation Engineer
Amgen
August 24, 2026
Full-time
On-site
West Greenwich, RI
Operations
Role: Validation Engineer within Amgen's Product Lifecycle Management organization, supporting manufacturing validation activities at a large-scale mammalian cell biotech plant. Objectives: ensure compliant validation of equipment, utilities, and systems for both clinical and commercial production, primarily in mammalian cell bioprocessing.
Responsibilities: develop and execute validation strategies and protocols for equipment (e.g., CIP, SIP, autoclaves), utilities, and systems; serve as technical expert during project planning, design reviews, and change management; oversee qualification activities, perform validation impact assessments, and troubleshoot validation issues; support cleaning validation and verification activities; drive continuous improvement and deliver training.
Qualifications: high school diploma with 8+ years manufacturing experience or associate’s degree with 6+ years, bachelor’s with 2+ years, or master’s degree; experience in GMP biopharma manufacturing, especially mammalian cell processes, with hands-on validation expertise including equipment qualification, sterilization, and cleaning validation. Knowledge of GMP, CFR/regulatory requirements, and technical documentation is essential.
Preferred: deep understanding of bioprocessing equipment, validation principles, regulatory expectations, and cross-functional collaboration skills across manufacturing, engineering, and quality teams.
High-Value: focus on biologics manufacturing, validation of production equipment and utilities, supporting clinical and commercial phases, in a GMP environment, with a Monday–Friday day shift at Rhode Island site.
Responsibilities: develop and execute validation strategies and protocols for equipment (e.g., CIP, SIP, autoclaves), utilities, and systems; serve as technical expert during project planning, design reviews, and change management; oversee qualification activities, perform validation impact assessments, and troubleshoot validation issues; support cleaning validation and verification activities; drive continuous improvement and deliver training.
Qualifications: high school diploma with 8+ years manufacturing experience or associate’s degree with 6+ years, bachelor’s with 2+ years, or master’s degree; experience in GMP biopharma manufacturing, especially mammalian cell processes, with hands-on validation expertise including equipment qualification, sterilization, and cleaning validation. Knowledge of GMP, CFR/regulatory requirements, and technical documentation is essential.
Preferred: deep understanding of bioprocessing equipment, validation principles, regulatory expectations, and cross-functional collaboration skills across manufacturing, engineering, and quality teams.
High-Value: focus on biologics manufacturing, validation of production equipment and utilities, supporting clinical and commercial phases, in a GMP environment, with a Monday–Friday day shift at Rhode Island site.