Engineer, Validation
ADMA Biologics, Inc.
September 03, 2026
Full-time
On-site
Boca Raton, FL
Operations
Role: Validation Engineer supporting ADMA Biologics' immunotherapy production, quality control, and plant engineering. Primary objectives include developing, reviewing, and executing qualification protocols for facilities, utilities, equipment, and computer systems, ensuring compliance with FDA regulations and GMP standards. Responsibilities encompass coordinating validation activities, maintaining validated states of equipment and facilities, supporting deviation investigations, reviewing protocols for cGxP compliance and data integrity, and collaborating with departments and validation contractors. The role involves interaction with FDA investigators regarding validation compliance.
Requirements: Bachelor's degree in science or engineering; 3+ years validation experience in a cGMP pharmaceutical/biological manufacturing environment. Preferred: strong knowledge of FDA regulations, validation strategies, and GMP practices.
HighValue: validation in biologics manufacturing, facilities/equipment qualification, cGxP compliance, FDA interaction, validation documentation, and cross-functional collaboration. Work setup: on-site in Boca Raton, FL, with no travel specified.
Requirements: Bachelor's degree in science or engineering; 3+ years validation experience in a cGMP pharmaceutical/biological manufacturing environment. Preferred: strong knowledge of FDA regulations, validation strategies, and GMP practices.
HighValue: validation in biologics manufacturing, facilities/equipment qualification, cGxP compliance, FDA interaction, validation documentation, and cross-functional collaboration. Work setup: on-site in Boca Raton, FL, with no travel specified.