Sr. QA Engineer - Validation Specialist

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. 

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, X, Instagram, and YouTube.

What We're Looking For

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.

YOUR ROLE

• 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
  
  

YOUR BACKGROUND

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