Quality Engineer, QA Validation

Staff Validation EngineerAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Working in a GMP environment, you'll develop and implement comprehensive validation strategies aligned with regulatory requirements and corporate standards. You'll collaborate with cross-functional teams to ensure the successful qualification of facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle. Your expertise will be vital in maintaining compliance, driving continuous improvement, and serving as a technical subject matter expert during audits and investigations. You'll have opportunities to mentor team members while working on diverse projects ranging from new product introductions to complex system validations.Requirements:5 or more years of medical device experienceExpert knowledge of cGMP regulations, GAMP 5, 21 CFR Part 11, and international regulatory requirementsStrong experience with validation lifecycle documentation including risk assessments, validation plans, IQ/OQ/PQ protocols, and summary reportsDemonstrated expertise in computerized system validation and data integrity requirementsExperience with manufacturing equipment, utilities, and facility qualificationProven project management skills and ability to lead multiple concurrent validation projectsStrong analytical and problem-solving capabilitiesExcellence in technical writing and documentationStrong communication and interpersonal skillsAbility to influence and coordinate activities across multiple departmentsProficiency with validation tools and standard office softwareExperience mentoring validation staffPhysical ability to work in both office and manufacturing environmentsEducation:• Advanced Degree preferred plus 6 years of experience, or bachelor's degree preferred plus 8 years of experience in validation experience in pharmaceutical/biotech manufacturing or related GMP environment• Preferred Fields of Study: Engineering, Science, Biotechnology, or related technical field