Staff Validation Engineer

Thermo Fisher Scientific • Greenville, NC

6d

About The Position

As part of Thermo Fisher Scientific, the Staff Validation Engineer contributes to global healthcare and scientific advancement by leading validation activities for critical systems, equipment, and processes that support the development and manufacturing of therapies.

In a GMP environment, this role develops and implements validation strategies aligned with regulatory requirements and corporate standards. The engineer collaborates with cross-functional teams to qualify facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle.

The position helps maintain compliance, drive continuous improvement, and serve as a technical subject matter expert during audits and investigations. It may also include mentoring team members and supporting projects such as new product introductions and complex system validations.

Requirements

• Advanced degree plus 6 years of validation experience, or a bachelor's degree plus 8 years of validation experience, in pharmaceutical or biotech manufacturing or a related GMP environment.
• 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.
• Excellent technical writing and documentation skills.
• 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.
• Ability to travel occasionally, less than 15%, as needed.
• Physical ability to work in both office and manufacturing environments.

Nice To Haves

• Preferred fields of study include Engineering, Science, Biotechnology, or a related technical field.

Responsibilities

• Lead validation activities for critical systems, equipment, and processes.
• Develop and implement validation strategies aligned with regulatory requirements and corporate standards.
• Collaborate with cross-functional teams to qualify 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 validation team members.
• Lead multiple concurrent validation projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior