Staff Validation Engineer

NCBioImpact; Greenville (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Staff Validation Engineer to lead validation activities for critical systems, equipment, and processes in a GMP environment. You will develop strategies, qualify facilities and equipment, and ensure data integrity across lifecycles.

You will collaborate with cross-functional teams, mentor staff, and support audits and investigations while contributing to product introductions and complex validations. Travel <15% may be required, based in the Greenville, NC area.

Qualifications

• Advanced degree with 6+ years of validation experience in pharma/biotech manufacturing or GMP environments.
• Bachelor's degree with 8+ years of validation experience in pharma/biotech manufacturing or GMP environments.
• Strong knowledge of cGMP regulations, GAMP 5, 21 CFR Part 11, and international regulatory requirements.
• Experience with validation lifecycle documentation (risk assessments, validation plans, IQ/OQ/PQ, summaries).
• Experience with validated computerized systems and data integrity requirements.
• Project management skills and ability to lead multiple validation projects.

Responsibilities

• Lead validation activities for facilities, utilities, equipment, and computerized systems.
• Develop and implement validation strategies aligned with regulatory requirements and corporate standards.
• Collaborate with cross-functional teams to ensure lifecycle qualification and compliance.
• Mentor team members and support audits and investigations.
• Support continuous improvement and execution of new product introductions and complex validations.

Skills

Analytical thinking

Problem solving

Communication skills

Interpersonal skills

Documentation

Education

Advanced degree

Bachelor's degree

Tools

Validation tools

Office software

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, 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 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

• 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
• Preferred Fields of Study: Engineering, Science, Biotechnology, or related technical field
• 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
• Travel occasionally (<15%) as needed
• Physical ability to work in both office and manufacturing environments