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 ForWe’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 ROLEAuthor, execute, and summarize validation protocols for equipment, utilities, and computer systemsCoordinate and manage validation projects, ensuring timely and compliant executionDevelop and revise procedures to align with cGMP, GLP, and FDA regulationsProvide technical input on new equipment and modifications to maintain validated statusSupport investigations related to critical equipment, processes, and utilitiesTrain personnel on validation procedures and compliance standardsRecommend policy and procedural changes to enhance regulatory complianceNotify management of deviations and recommend corrective actions for out-of-spec systemsConduct special projects and provide technical support as directed by managementMaintain a safe working environment and report safety or environmental concerns promptlyYOUR BACKGROUNDEducationBachelor’s degree in Engineering, Life Sciences, or equivalent validation experienceExperience2–6 years of validation experience in a pharmaceutical manufacturing environmentSkills/CompetenciesStrong knowledge of cGMP, GLP, and FDA regulationsExperience with pharmaceutical equipment, cleaning validation, and steam sterilizationProficiency in writing protocols, reports, and technical documentationAbility to apply advanced mathematical and statistical principlesSkilled in problem-solving, data analysis, and drawing valid conclusionsProficient in MS Office (Word, Excel, PowerPoint, Access) and database toolsEffective communicator with strong technical writing and interpersonal skillsSelf-motivated, organized, and capable of managing multiple prioritiesDemonstrated accountability and ability to meet deadlines with high accuracy