Quality Engineer, QA Validation
Thermo Fisher Scientific · Greenville, North Carolina, USA ·
- Category
- QA
- Experience
- 6+ years
- Company size
- 1000+
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