Quality Engineer, QA Validation Thermo Fisher Scientific - 3.4 Greenville, NC Job Details Full-time 1 day ago Qualifications Data integrity assurance GAMP Content creation for technical audiences Technical documentation Pharmaceutical regulatory compliance Technical writing experience within manufacturing
FDA 21 CFR
Part 11 Project management experience in manufacturing Data summary reports Manufacturing facility experience Data integrity and documentation Production validation processes Quality risk management Project management experience in healthcare Compliance documentation Mentoring Biomedical regulatory compliance Manufacturing Cross-functional collaboration Cross-functional communication Pharmaceutical manufacturing facility experience Engineering quality assurance Full Job Description Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP)
Safety Standards, Cleanroom:
no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As 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.
DESCRIPTION
Join our QA Validation team at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. As a Staff Validation Engineer, you'll lead validation activities for critical systems, equipment, and processes that enable the development and manufacturing of therapies. 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 experience Expert knowledge of cGMP regulations, GAMP 5, 21 CFR Part 11, and international regulatory requirements Strong experience with validation lifecycle documentation including risk assessments, validation plans, IQ/OQ/PQ protocols, and summary reports Demonstrated expertise in computerized system validation and data integrity requirements Experience with manufacturing equipment, utilities, and facility qualification Proven project management skills and ability to lead multiple concurrent validation projects Strong analytical and problem-solving capabilities Excellence in technical writing and documentation Strong communication and interpersonal skills Ability to influence and coordinate activities across multiple departments Proficiency with validation tools and standard office software Experience mentoring validation staff Physical ability to work in both office and manufacturing environments
EDUCATION
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
