Quality Engineer, QA Validation

About the role

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.

Responsibilities

• Lead validation activities for critical systems, equipment, and processes
• Develop and implement comprehensive validation strategies aligned with regulatory requirements and corporate standards
• Collaborate with cross-functional teams to ensure successful qualification of facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle
• Maintain compliance and drive continuous improvement
• Serve as technical subject matter expert during audits and investigations
• Mentor team members on validation projects
• Manage 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

Qualifications

• 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