Staff Validation Engineer — GMP & System Qualification

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

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.