Quality Engineer, QA Validation
About The Position
Join the QA Validation team at Thermo Fisher Scientific to contribute to global healthcare and scientific advancement. As a Staff Validation Engineer, you will lead validation activities for critical systems, equipment, and processes essential for the development and manufacturing of therapies. Working in a GMP environment, you will be responsible for developing and implementing comprehensive validation strategies that align with regulatory requirements and corporate standards. This role involves collaboration with cross-functional teams to ensure the successful qualification of facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle. Your expertise will be crucial in maintaining compliance, driving continuous improvement, and acting as a technical subject matter expert during audits and investigations. You will also have opportunities to mentor team members and work on diverse projects, 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
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in validation experience in pharmaceutical/biotech manufacturing or related GMP environment
Nice To Haves
- Preferred Fields of Study: Engineering, Science, Biotechnology, or related technical field
Responsibilities
- Lead validation activities for critical systems, equipment, and processes that enable the development and manufacturing of therapies
- Develop and implement comprehensive validation strategies aligned with regulatory requirements and corporate standards
- Collaborate with cross-functional teams to ensure the successful qualification of facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle
- Maintain compliance and drive continuous improvement
- Serve as a technical subject matter expert during audits and investigations
- Mentor team members
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
