Sr. QA Engineer - Validation Specialist

Overview

At Guerbet, we build lasting relationships so that we enable people to live better. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate. Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice.

We’re seeking a highly motivated and detail-oriented Sr. QA Engineer – Validation Specialist to lead and support validation activities across equipment, utilities, and computer systems in a pharmaceutical manufacturing environment. This role is essential to ensuring compliance with cGMP, GLP, and FDA regulations while driving continuous improvement and operational excellence. You’ll collaborate with cross-functional teams, provide technical guidance, and take ownership of validation deliverables from planning through execution.

This is an on-site position located in Raleigh, NC.

• 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

Education

• Bachelor’s degree in Engineering, Life Sciences, or equivalent validation experience

Experience

• 2–6 years of validation experience in a pharmaceutical manufacturing environment

Skills/Competencies

• Strong knowledge of cGMP, GLP, and FDA regulations
• Experience with pharmaceutical equipment, cleaning validation, and steam sterilization
• Proficiency in writing protocols, reports, and technical documentation
• Ability to apply advanced mathematical and statistical principles
• Skilled in problem-solving, data analysis, and drawing valid conclusions
• Proficient in MS Office (Word, Excel, PowerPoint, Access) and database tools
• Effective communicator with strong technical writing and interpersonal skills
• Self-motivated, organized, and capable of managing multiple priorities
• Demonstrated accountability and ability to meet deadlines with high accuracy