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Guerbet · 1 month ago

Sr. QA Engineer - Validation Specialist

Raleigh, NC

Full-time

Onsite

Mid, Senior Level

2+ years exp

Guerbet is a global leader in medical imaging, offering innovative solutions for diagnostic and interventional imaging. They are seeking a highly motivated Sr. QA Engineer – Validation Specialist to lead validation activities in a pharmaceutical manufacturing environment, ensuring compliance with cGMP, GLP, and FDA regulations while driving operational excellence.

Health CareMedicalPharmaceutical

Responsibilities

Author, execute, and summarize validation protocols for equipment, utilities, and computer systems

Coordinate and manage validation projects, ensuring timely and compliant execution

Develop and revise procedures to align with cGMP, GLP, and FDA regulations

Provide technical input on new equipment and modifications to maintain validated status

Support investigations related to critical equipment, processes, and utilities

Train personnel on validation procedures and compliance standards

Recommend policy and procedural changes to enhance regulatory compliance

Notify management of deviations and recommend corrective actions for out-of-spec systems

Conduct special projects and provide technical support as directed by management

Maintain a safe working environment and report safety or environmental concerns promptly

Qualification

CGMP regulationsGLP regulationsFDA regulationsValidation experienceData analysisTechnical documentationProblem-solvingInterpersonal skillsTechnical writingOrganizational skills