Staff Validation Engineer

Thermo Fisher Scientific • Greenville, NC

4d

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 therapy development and manufacturing. In a GMP environment, the engineer develops and implements comprehensive validation strategies aligned with regulatory requirements and corporate standards.

The role collaborates with cross-functional teams to qualify facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycles. It supports compliance and continuous improvement, serves as a technical subject matter expert during audits and investigations, and may mentor team members. Projects include new product introductions and complex system validations.

The standard work schedule is Monday through Friday. The working environment includes office and manufacturing areas and requires adherence to GMP safety standards. In cleanrooms, restrictions apply to hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair. Some personal protective equipment may be required, such as safety glasses, gowns, gloves, lab coats, or ear plugs.

Requirements

• Advanced degree plus 6 years of validation experience, or 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.
• 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.
• 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.
• Experience mentoring validation staff.

Responsibilities

• Lead validation activities for critical systems, equipment, and processes supporting therapy development and manufacturing.
• Develop and implement validation strategies aligned with regulatory requirements and corporate standards.
• Coordinate qualification of facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycles.
• Maintain compliance and drive continuous improvement.
• Serve as a technical subject matter expert during audits and investigations.
• Mentor validation team members.
• Lead validation projects, including new product introductions and complex system validations.

What This Job Offers

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